Identity
- Trade Name
- Clamp FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
- Device Name
- Cooley Angeld Clamp w/ Serrated 12mm Jaw, 17.5cm 6-3/4" FDA UDI
- Model / Reference
- 8509-20 FDA UDI
- Description
- Cooley Angeld Clamp w/ Serrated 12mm Jaw, 17.5cm 6-3/4" FDA UDI
Identifiers
- Catalog Number
- 8509-20 FDA UDI
- Primary DI / UDI-DI
- 10840199535894 FDA UDI
- FDA Product Code
- HXD FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Clamp by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical soft-tissue manipulation forceps, tweezers-like, reusable.
- Micro-Pliers 17, 5 cm, lightweight, DCL coated — SALVIN DENTAL SPECIALTIES, LLC · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- STILLE Titanium Micro Forceps — Stille AB · Class I
- Gen2 — SURGIX MEDICAL LLC · Class I
- TISSUE FORCEPS SEMKEN 6" SERRATED STRAIGHT — W.H. Holden, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koros USA, Inc.
Sources (1)
- FDA UDI b4c1ab26-fda9-42b2-ba71-21682cf998c3 37 fields · synced May 30, 2026