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Bovie

FDA UDI

Class II (US FDA UDI)

by Bovie Medical Corporation

Identity

Trade Name
BOVIE FDA UDI
Generic Name
Electrocautery system generator, battery-powered FDA UDI
Device Name
DISPOSABLE SHEATH FOR REPLACEABLE CAUTERY FDA UDI
Model / Reference
HISL FDA UDI
Description
DISPOSABLE SHEATH FOR REPLACEABLE CAUTERY FDA UDI

Identifiers

Catalog Number
HISL FDA UDI
Primary DI / UDI-DI
00607151071639 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrocautery system generator, battery-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocautery system generator, battery-powered

Bovie by Bovie Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocautery system generator, battery-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bovie Medical Corporation

Sources (1)

  • FDA UDI 3178db4c-1aed-45bf-a5f5-38d1fe3ae18b 34 fields · synced Jun 1, 2026