Identity
- Trade Name
- Bovie FDA UDI
- Generic Name
- Electrocautery system handpiece FDA UDI
- Device Name
- AUTOCLAVABLE 3 - BUTTON POWER CONTROL HANDPIECE FDA UDI
- Model / Reference
- A901 FDA UDI
- Description
- AUTOCLAVABLE 3 - BUTTON POWER CONTROL HANDPIECE FDA UDI
Identifiers
- Catalog Number
- A901 FDA UDI
- Primary DI / UDI-DI
- 00607151019013 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrocautery system handpiece 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrocautery system handpiece
Bovie by Bovie Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocautery system handpiece.
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- IMCO — INDEPENDENT MEDICAL CO-OP, INC. · Class II
- Geiger TCU Handpiece — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Pro Advantage — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class II
- Electrode Handpiece, Hand Activated — GYNEX CORPORATION · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bovie Medical Corporation
Sources (1)
- FDA UDI bcdb0aaf-d90a-41f5-b382-ecd14b0bd499 34 fields · synced May 29, 2026