ESU pencil

Disposable Electrosurgical Pencil Assembled with Electrosurgical Generators. To avoid burns during operation. ISO13485

Disposable Electrosurgical Pencil

Specification:

1. Length of ABS handle (mm):160mm

2. Length of stainless steel blade(mm):40mm, 70mm, 80mm, 100mm,120mm,160mm

3. Diameter of blade: 2.3mm

4. Length of cable (m):3.0m

5. 3 pins banana plug

6. Function: cut & coagulate

 

Features:

1. Hand control.

2. Inside Hexagon lock provides precision and reliability.

3. Individual Sterile package, with an inner plastic bag & a plastic+ paper bag. Sealed design prevents leakage.

4. Sterile Way: E.O.

5. Professional manufacturer.

6. ISO13485 certificate

 

Item NO.	Specification	Packing
0101-04	4cm	100pcs/carton
0101-08	8cm	100pcs/carton
0101-12	12cm	100pcs/carton
0101-16	16cm	100pcs/carton
0102-04	by absorber	100pcs/carton

ESU pencil

Verified Information This information is Verified by Bureau Veritas and validity period is 2012/09/05 --- 2013/09/05 All the information below may covers both Gold Supplier and its related companies , Their Relationship will be affirmed according to china laws and regulations , also it will be clearly display in the full report >> Production Capacity: Product line name Production Line Capacity Actual Units Produced(Previous Year)

Disposable Fixing Set of Tracheal Cannula, Disposable Patient Plate, Disposable Bacterial / Viral Filter, Disposable Anesthesia, Disposable Anesthesia Puncture Kit, Disposable Pressure Transducer	Disposable Fixing Set of Tracheal Cannula 10,000 Pcs/Month Disposable Patient Plate 60,000 Pcs/Month Disposable Bacterial / Viral Filter 42,000 Pcs/Month Disposable Anesthesia 45,000 Sets/Month Disposable Anesthesia Puncture Kit 45,000 Bags/Month Disposable Pressure Transducer 5,000 Pcs/Month	67,044 Pcs 145,378 Pcs 251,252 Pcs 251,633 Sets 346,998 Bags 28,287 Pcs

Export Market Distribution: Market Revenue(Previous Year) Total Revenue (%)

South America	USD 160,000	3.42
Southeast Asia	USD 95,000	2.03
Africa	USD 155,000	3.31
Mid East	USD 234,000	5.0
Western Europe	USD 130,000	2.77
Domestic Market	USD 3,910,000	83.47

Production Machinery: Machine Name Brand & Model No. Quantity Number of Year(s) Used Condition

Medical Wound Dressing Pad Machine	FL-20	1	11.0	Acceptable
Automatic Plastic Suction Machine	AVF-2000-A/C	1	8.0	Acceptable
Die Cutting Machine	CL68	1	8.0	Acceptable
Die Cutting Machine	CLP4-30	1	2.0	Acceptable
Plastic Injection Machine	No Information	8	6.0	Acceptable
Precise Extrusion Machine	No Information	4	2.0	Acceptable
Bubble Cap Packing Machine	XB40A	1	6.0	Acceptable

Testing Machinery: Machine Name Brand & Model No. Quantity Number of Year(s) Used Condition

Biochemical Culture Chamber	SPX-150B-Z	1	6.0	Acceptable
Mycete Culture Chamber	160B-Z	1	5.0	Acceptable
PH Meter	PHS-25	1	5.0	Acceptable
Luminometer	721	1	5.0	Acceptable
Pulling Tester	QJ-211C	1	4.0	Acceptable
Electric Conductivity Meter	DDS-II	1	4.0	Acceptable

Production Flow: 1.Extruding 2.Injecting 3.Plastic Suction Processing 4.Die Cutting 5.Medical Wound Dressing Pad Making 6.Bubble Cap Packing 7.Assembling 1 8.Semi-Packing 9.Assembling 2 10.Sewing 11.Assembling 3 12.Assembling 4 13.Final Packing Certification: Certified Picture Certification Name Certified By Certificate No. Product Name & Model No. Available Date-Expired Date

	ISO9001:2008	Beijing Hua Guang Certification of Medical Devices Co., Ltd. CNAS	04711Q10112R2M	The Design, Development, Production and Service of Disposable Sterile Urethral Catheterization Kit, Medical Wound Dressing Pad, Disposable Trachea Canula Kit for General Anesthesia, Disposable Anesthesia Puncture Kit, Cleaning Pad for Electrosurgical Pencil Blade, Disposable Fixed Set of Trachea Canula, Disposable Laryngoscope Blade, Disposable Anesthesia Breathing Circuit, Disposable Monopolar Electrosurgical Pencil, Disposable Anesthesia Mask, Soda lime (Carbon Dioxide Absorbent), indifferent plate Electrode, Disposable Laryngeal Mask Airway, Disposable Tracheotomy Tube / Endotracheal Tube, Calcium Lime (Carbon Dioxide Absorbent), Disposable Pulse Oximeter Probe / Oropharyngeal Airway / Nasopharyngeal Airway / Absorber of Anesthesia Exhaust Gas / Nasal Oxygen Cannula / Endotracheal Double-way Tube / Strengthen Endotracheal Tube / Three-way Stopcock String / Central Venous Catheter Puncture Kit / Pressure Transducer / Oxygen Mask / Humidifier Bottle / Humidifying Nasal Catheter / Bacterial and Viral Filter.	2011/05/06 --- 2014/05/05
	ISO13485:2003	Beijing Hua Guang Certification of Medical Devices Co., Ltd.	04711Q10000103	The Design, Development, Production and Service of Disposable Sterile Urethral Catheterization Kit, Medical Wound Dressing Pad, Disposable Trachea Canula Kit for General Anesthesia, Disposable Anesthesia Puncture Kit, Cleaning Pad for Electrosurgical Pencil Blade, Disposable Fixed Set of Trachea Canula, Disposable Laryngoscope Blade, Disposable Anesthesia Breathing Circuit, Disposable Monopolar Electrosurgical Pencil, Disposable Anesthesia Mask, Soda lime (Carbon Dioxide Absorbent), indifferent plate Electrode, Disposable Laryngeal Mask Airway, Disposable Tracheotomy Tube / Endotracheal Tube, Calcium Lime (Carbon Dioxide Absorbent), Disposable Pulse Oximeter Probe / Oropharyngeal Airway / Nasopharyngeal Airway / Absorber of Anesthesia Exhaust Gas / Nasal Oxygen Cannula / Endotracheal Double-way Tube / Strengthen Endotracheal Tube / Three-way Stopcock String / Central Venous Catheter Puncture Kit / Pressure Transducer / Oxygen Mask / Humidifier Bottle / Humidifying Nasal Catheter / Bacterial and Viral Filter.	2011/05/06 --- 2014/05/05
	ISO13485:2003	TUV SUD, ZLC	Q1N110967628008	Product Name & Model No.Scope:Design and Development, Production and Distribution of Disposable Pressure Transducer, Disposable Patient Plate, Production and Distribution of Disposable Tracheal Cannula kit for General Anesthesia, Disposable Bacterial /Viral Filter, Catheterization Assistance Kit, Assistant Kit for Clinic Cure, Disposable Anesthesia Breathing Circuit, Dressing Pad, Disposable Laryngoscope Blade, Disposable Fixing Set of Tracheal Cannula, Disposable Electrosurgical Pencil (Hand Control & Foot Control), Disposable Spare Kit, Irrigation Syringe and Kit, Disposable Assistant Kit for Gastroscope, Disposable Anesthesia Puncture Kit, Disposable Skin Staple Remover, Disposable Central Venous Catheter Puncture Kit, Anesthesia Mask, Soda Lime (Absorbent of Carbon Dioxide), Disposable Endotracheal Tube, Disposable Tracheotomy Tube, Disposable Laryngeal Mask Airway, Disposable Nasopharyngeal Airway, Disposable Oropharyngeal Airway, Disposable Oxygen Mask	2012/03/05 --- 2014/11/30
	CE	TUV SUD	G2S081267628003	Disposable patient plate, Disposable skin staple remover	2009/03/16 --- 2012/12/04
	CE	TUV SUD	G1081267628004	Disposable pressure transducer	2009/03/16 --- 2014/03/03
	CE	TUV SUD	G2101067628007	Disposable anesthesia breathing circuit, Disposable bacterial/viral filter, Catheterization assistance kit, Disposable anesthesia puncture kit, Disposable trachea canula kit for general anesthesia, Dressing pad, Anesthesia mask, Soda lime( absorbent of carbon dioxide)	2010/12/15 --- 2015/12/14
	CE	TUV SUD	G2110967628010	Disposable anesthesia breathing circuit, Disposable bacterial/viral filter, Catheterization assistance kit, Disposable anesthesia puncture kit, Disposable trachea canula kit for general anesthesia, Dressing pad, Anesthesia mask, Soda lime( absorbent of carbon dioxide), Disposable endotracheal tube, Disposable laryngeal mask airway, Disposable oxygen mask	2012/03/05 --- 2015/12/14
	CE	TUV SUD	G2S110967628011	Disposable skin staple remover, Disposable laryngoscope blade, Disposable fixing set of tracheal cannula, Disposable nasopharyngeal airway, Disposable oropharyngeal airway	2012/03/05 --- 2015/12/14

Testing Report: Report Picture Report Name Report By Product Name & Model No. Report Date

	Test Report	Zhejiang Institute for the Control Medical Device	Disposable Anesthesia 1.0m	2008/10/07
	Test Report	Hangzhou Medical Device Supervising & Testing Center of SFDA	Disposable Pressure Transducer & DBFT-0103	2009/03/10
	Test Report	Guangzhou Medical Device Supervising & Testing Center of SFDA	Disposable Patient Plate & HPP212	2011/06/27
	Test Report	Guangzhou Medical Device Supervising & Testing Center of SFDA	Disposable Anesthesia Puncture Kit & AS-E/S 1.6X80	2012/07/04