Identity
- Trade Name
- Universal Tendon Spacer FDA UDI
- Generic Name
- Tendon sheath regeneration implant FDA UDI
- Model / Reference
- 0232-01-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700751502132 FDA UDI
- 510(k) Number
- K243477 FDA UDI
- FDA Product Code
- HXA FDA UDI
- GMDN Term
- Tendon sheath regeneration implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Category: Tendon sheath regeneration implant
Universal Tendon Spacer by Askorn Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon sheath regeneration implant.
- HUNTER — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- HUNTER — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- HUNTER — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- HUNTER — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- HUNTER — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- HUNTER — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- HUNTER — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- HUNTER — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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
- Askorn Medical
Sources (1)
- FDA UDI 1309ef54-50b7-40b9-8b70-762462c36028 33 fields · synced May 30, 2026