Identity
- Trade Name
- Combifix™ FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kneefix™ cushion FDA UDI
- Model / Reference
- 151004 FDA UDI
- Description
- baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kneefix™ cushion FDA UDI
Identifiers
- Catalog Number
- 151004 FDA UDI
- Primary DI / UDI-DI
- 00841439109946 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Combifix™ by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K060737 also covers:
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Immobilizer — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posifix® -2 Baseplate — Medtec LLC
- Posifix® Headrest — Medtec LLC
- Posifix® Headrest — Medtec LLC
K180021 also covers:
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- Patient Hand Grip — Medtec LLC
- Pediatric Cushion Guide — Medtec LLC
- Pediatric Registration Film — Medtec LLC
- Positioning Cushion — Medtec LLC
- ProForm™ Pediatric Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
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
- Medtec LLC
Sources (1)
- FDA UDI 3e316d97-79cb-4c82-99db-6717233ff526 37 fields · synced Jun 1, 2026