Identity
- Trade Name
- LLETZ Braun Tenaculum FDA UDI
- Generic Name
- Uterine fibroid hook FDA UDI
- Model / Reference
- LT2250 FDA UDI
Identifiers
- Primary DI / UDI-DI
- GYNXLT22500 FDA UDI
- 510(k) Number
- K980247 FDA UDI
- FDA Product Code
- HDC FDA UDI
- GMDN Term
- Uterine fibroid hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Uterine fibroid hook
LLETZ Braun Tenaculum by Gynex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uterine fibroid hook.
- Braun Tenaculum — GYNEX CORPORATION · Class II
- LLETZ Iris Hook — GYNEX CORPORATION · Class II
- Angle Hook — GYNEX CORPORATION · Class II
- LLETZ Angle Hook — GYNEX CORPORATION · Class II
- Schroeder Tenaculum, Angled — GYNEX CORPORATION · Class II
- Iris Hook — GYNEX CORPORATION · Class II
- Schroeder Tenaculum — GYNEX CORPORATION · Class II
- Braun Tenaculum, Angled — GYNEX CORPORATION · Class II
Cleared under the same submission
K980247 also covers:
- 2-Prong Hook — GYNEX CORPORATION
- 3-Prong Hook — GYNEX CORPORATION
- Angle Hook — GYNEX CORPORATION
- Braun Tenaculum — GYNEX CORPORATION
- Braun Tenaculum, Angled — GYNEX CORPORATION
- Braun Tenaculum, Bariatric — GYNEX CORPORATION
- Emmett Tenaculum — GYNEX CORPORATION
- Iris Hook — GYNEX CORPORATION
- LLETZ Angle Hook — GYNEX CORPORATION
- LLETZ Braun Standard Tenaculum — GYNEX CORPORATION
- LLETZ Emmett Tenaculum — GYNEX CORPORATION
- LLETZ Iris Hook — GYNEX CORPORATION
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
- Gynex Corporation
Sources (1)
- FDA UDI f2226099-6eb2-4cf6-8e84-c50f0565a7bd 33 fields · synced Jun 1, 2026