FDA CE Certified OBS Disposable Electrosurgical Pencil--Certified FDA 510 CE

Specifications
Certified ISO13485, CE1023 by ITC, FDA 510(k) Company FDA Registation No.: 3007748793
Device K No.:K092634
CE MarkThese devices are designed to be used as accessories in conjunction with those electrosurgical units and electrodes. These devices are single use supplied sterile. Check plug matching on generator base and connect. Press CUT/yellow button for cutting and COAG/blue button for coagulation. Maximum voltage is not be exceed 90KV peak
Electrical Performance Data
Maximal Output Current
Frenquency Confine
Current Resistence
Output Power
1A
0-1.0MHz
200Ω
50-80W
Warning
These devices should never be used when:
There is visible evidence of damage to the exterior of the device such as cracked or damaged plastic or connector damage.
These devices fail the inspection described herein.
In the presence of flammble gases, flammable prep solutions or drapes. Oxidizing. Gases such as Nitrous Oxide (N2O),or in oxygen-riched environments.
Do not used monopolar electrosurgery on small appendages, as in circumcision or finger surgery.Content
Net Weight
Gross Weight
Carton Size
Paper Packaging
100 pcs/ctn
6.8kg
7.3kg
36*27*28
Blister Packaging
25 pcs/ inner ctn;
4 inner ctns/outer ctn
9.8kg
11.5kg
53.5*36*40