Identity
- Trade Name
- Bovie FDA UDI
- Generic Name
- Electrocautery system generator, battery-powered FDA UDI
- Device Name
- Replacement Tip Fine Elongated (10/bx) FDA UDI
- Model / Reference
- H104 FDA UDI
- Description
- Replacement Tip Fine Elongated (10/bx) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10887482179601 FDA UDI
- 510(k) Number
- K945758 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
Yes
FDA UDI
Category: Electrocautery system generator, battery-powered
Bovie by Symmetry Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K945758 also covers:
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
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 |
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Manufacturer
- Manufacturer
- Symmetry Surgical Inc.
Sources (1)
- FDA UDI 007a99a4-fdc3-4d34-bafa-9f4484f925ca 35 fields · synced Jun 8, 2026