Identity
- Trade Name
- Traction unit FDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Model / Reference
- 11443 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350111832537 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- External orthopaedic fixation system, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External orthopaedic fixation system, reusable
Traction unit by Reison Medical AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, reusable.
- HOFFMANN — Stryker Corp. · Class II
- ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- Integra® External Fixation System — Ascension Orthopedics, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- TransFx™ — Zimmer, Inc. · Class I
- HOFFMANN — Stryker Corp. · Class II
- SIDEKICK — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Reison Medical AB
Sources (1)
- FDA UDI 9d5ecd63-6ffd-46aa-acf2-e6b34479071c 32 fields · synced May 31, 2026