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kVue™ PentaFix™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4549KVModel Couchtops, Overlays, and Multipurpose Devices
by Qfix
Identity
- Trade Name
- kVue™ PentaFix™ FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- kVue Pentafix Insert FDA UDI
- Model / Reference
- RT-4549KV EUDAMEDFDA UDICouchtops, Overlays, and Multipurpose Devices EUDAMED
- Description
- kVue Pentafix Insert FDA UDI
Identifiers
- Catalog Number
- RT-4549KV FDA UDI
- Primary DI / UDI-DI
- 10841962108864 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621COUCHTOPSMPD6F EUDAMED
- FDA Product Code
- JAI FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5770 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Patient positioner base plate
kVue™ PentaFix™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioner base plate.
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- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI fb0f176f-81fd-46c9-8752-d30137931c52 35 fields · synced Jun 18, 2026
- EUDAMED 41e353ce-566f-48b9-92fb-e519bd20f566 61 fields · synced Jun 18, 2026