Identity
- Trade Name
- AccuFix™ FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- AccuFix MRI Cantilever Board FDA UDI
- Model / Reference
- RT-4525LMRI FDA UDI
- Description
- AccuFix MRI Cantilever Board FDA UDI
Identifiers
- Catalog Number
- RT-4525LMRI FDA UDI
- Primary DI / UDI-DI
- 10841962108543 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Patient positioner base plate
AccuFix™ by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioner base plate.
- Meicen — Guangdong Meicen Medical Equipment Co., Ltd. · Class I
- Type-S™ Variable Axis Baseplate — Medtec LLC · Class II
- Posifix® -2 Baseplate — Medtec LLC · Class II
- MR Posi-S™ Adapter — Medtec LLC · Class II
- Uni-frame® Baseplate — Medtec LLC · Class II
- Prone Head Holder — Medtec LLC · Class I
- Arthrex TRIMANO quick adapter — Maquet, Inc. · Class I
- Uni-frame® Baseplate — Medtec LLC · 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
- Qfix
Sources (1)
- FDA UDI e0300253-749a-4a2b-816c-47c7864ec08f 35 fields · synced Jun 7, 2026