Identity
- Trade Name
- LEEP Three- Prong Hook FDA UDI
- Generic Name
- Uterine tenaculum FDA UDI
- Device Name
- LEEP Three- Prong Hook - Coated 260 mm FDA UDI
- Model / Reference
- F803 FDA UDI
- Description
- LEEP Three- Prong Hook - Coated 260 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937016314 FDA UDI
- FDA Product Code
- HFB FDA UDI
- GMDN Term
- Uterine tenaculum FDA UDI
Classification
- Device Class
- Class I 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
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
Yes
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
Dimensions & Sizes
- Size
- Length — 260 Millimeter FDA UDI
Category: Uterine tenaculum
LEEP Three- Prong Hook by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- GEN2 — SURGIX MEDICAL LLC · Class II
- GEN2 — SURGIX MEDICAL LLC · Class II
- Hayden Medical — Hayden Medical 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 I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI d7238edc-0313-44f7-ae44-cb7196ec2ab6 34 fields · synced Jun 9, 2026