Identity
- Trade Name
- Hernia bridge FDA UDI
- Generic Name
- Spinal surgery positioning board FDA UDI
- Model / Reference
- 10-485 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350111832469 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Spinal surgery positioning board 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Spinal surgery positioning board
Hernia bridge by Reison Medical AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal surgery positioning board.
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- AIS Patient Positioner — ALPHATEC SPINE, INC. · Class I
- Lateral Patient Positioning System — ALPHATEC SPINE, INC. · Class I
- Lateral Patient Positioning System — ALPHATEC SPINE, INC. · Class I
- Support plate — Maquet, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Reison Medical AB
Sources (1)
- FDA UDI 954dc8f8-11be-4d93-a609-04dfc008bbd9 32 fields · synced May 31, 2026