Identity
- Trade Name
- STEALTH® CLAMP INSERT FDA UDI
- Generic Name
- Clamp jaw cover FDA UDI
- Device Name
- CLAMP INSERT FDA UDI
- Model / Reference
- A0C04 FDA UDI
- Description
- CLAMP INSERT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915113094 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
Stealth® Clamp Insert by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Clamp jaw cover.
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- 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 063436cb-91c7-43fe-b073-32dfefe1e517 35 fields · synced May 31, 2026