Identity
- Trade Name
- TEHLIN FDA UDI
- Generic Name
- Mechanical-resistance external knee prosthesis FDA UDI
- Device Name
- HY-STAN 4 BAR KNEE WITH MANUAL LOCK FDA UDI
- Model / Reference
- C-TK-4001S FDA UDI
- Description
- HY-STAN 4 BAR KNEE WITH MANUAL LOCK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719883460301 FDA UDI
- FDA Product Code
- ISY FDA UDI
- GMDN Term
- Mechanical-resistance external knee prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 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
No
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
Yes
FDA UDI
Category: Mechanical-resistance external knee prosthesis
Tehlin by Teh Lin Prosthetic & Orthopaedic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Slide.fit — Streifeneder ortho.production GmbH · Class I
- Victor — COLLEGE PARK INDUSTRIES, INC. · Class I
- Slide.fit — Streifeneder ortho.production GmbH · Class I
- Modular Single Axis Knee Joint — Streifeneder ortho.production 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 |
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Manufacturer
- Manufacturer
- Teh Lin Prosthetic & Orthopaedic, Inc.
Sources (1)
- FDA UDI 7f06ada5-fa88-4493-a4ff-18eadc99e747 33 fields · synced Jun 1, 2026