Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Tendon stripper FDA UDI
- Device Name
- TENOLYSIS KNIFE #4 FDA UDI
- Model / Reference
- 11094-04 FDA UDI
- Description
- TENOLYSIS KNIFE #4 FDA UDI
Identifiers
- Catalog Number
- 11094-04 FDA UDI
- Primary DI / UDI-DI
- 00198506058523 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Tendon stripper 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Tendon stripper
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon stripper.
- Ambler Surgical — Ambler Surgical, LLC · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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
- Elmed Incorporated
Sources (1)
- FDA UDI f6dc8a86-8a46-465d-950c-b0315d6d7b1c 35 fields · synced Jun 8, 2026