MONOPOLAR HANDPIECE WITH 8 FOOT DOUBLE INSULATED CORD

MONOPOLAR HANDPIECE WITH 8 FOOT DOUBLE INSULATED CORD
Bovie - A801

A handle-like device that is attached (clips or is slid onto the cylindrical barrel) to an electrically- or pneumatically-powered surgical power tool handpiece or motor of the micro types (a drill or a saw) so that the two devices interact to function as a switch used by the operating surgeon to hand activate (start and stop) the handpiece/motor. It is typically made of metal and/or synthetic materials and will typically include a sliding lock that, when brought into use by the surgeon, will lock the handle in the "On" position. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: GEI

Device Name: Electrosurgical, Cutting & Coagulation & Accessories

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Device Id: 00607151018016

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A