Identity
- Trade Name
- STEALTH® FIBRA® CLAMP INSERT FDA UDI
- Generic Name
- Clamp jaw cover FDA UDI
- Device Name
- CLAMP INSERT FDA UDI
- Model / Reference
- A0G04 FDA UDI
- Description
- CLAMP INSERT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915114756 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Clamp jaw cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 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
No
FDA UDI
Category: Clamp jaw cover
A medical device used in pairs to improve atraumatic grip and pressure distribution when clamping an artery or vein. This long cylindrical polymer tube is typically available in various sizes, making it suitable for a range of surgical applications.
Similar devices
Also classified as Clamp jaw cover.
- HU-FRIEDY — HU-FRIEDY MFG CO., LLC · Class I
- Sterion®Clamp Cover Fabric — Aspen Surgical Products, Inc. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Sterion®Clamp Cover Fabric — Aspen Surgical Products, Inc. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Sterion®Clamp Cover Fabric — Aspen Surgical Products, Inc. · Class I
- Axiom® Clamp Sleeves — AXIOM MEDICAL, INCORPORATED · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI c53ee37f-fb86-45d2-aecb-4247ca2c9210 35 fields · synced Jul 31, 2026