Identity
- Trade Name
- OP Rongeur FDA UDI
- Generic Name
- Craniofacial rongeur, reusable FDA UDI
- Device Name
- Osteo-Punch Cutting Blade Ejector Tip Shaft Only 2mm x 90 Degree 7" FDA UDI
- Model / Reference
- 7377-22E FDA UDI
- Description
- Osteo-Punch Cutting Blade Ejector Tip Shaft Only 2mm x 90 Degree 7" FDA UDI
Identifiers
- Catalog Number
- 7377-22E FDA UDI
- Primary DI / UDI-DI
- 10840199519535 FDA UDI
- FDA Product Code
- HTX FDA UDI
- GMDN Term
- Craniofacial rongeur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Spinal rongeurOrthopaedic joint/limb rongeurCraniofacial rongeur, reusableRib rongeur
OP Rongeur by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rib rongeur.
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- Sklar — Sklar Corporation · Class I
- Sklar — Sklar Corporation · Class I
- Symmetry DE VILBISS — SYMMETRY SURGICAL INC. · Class II
- V. Mueller — STERIS CORPORATION · 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 |
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Manufacturer
- Manufacturer
- Koros USA, Inc.
Sources (1)
- FDA UDI 26683507-23ed-46f7-a0eb-617a0c17047b 37 fields · synced May 30, 2026