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BoS™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4535KV02Model Head and Neck
by Qfix
Identity
- Trade Name
- BoS™ FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- kVue™ BoS™ Insert without Virtual Indexing 158cm Long FDA UDI
- Model / Reference
- RT-4535KV02 EUDAMEDFDA UDIHead and Neck EUDAMED
- Description
- kVue™ BoS™ Insert without Virtual Indexing 158cm Long FDA UDI
Identifiers
- Catalog Number
- RT-4535KV02 FDA UDI
- Primary DI / UDI-DI
- 10841962110959 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621HEADNECKX4 EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
Dimensions & Sizes
- Size
- Length — 158 Centimeter FDA UDI
Category: Patient positioner base plate
BoS™ 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.
- Meicen — Guangdong Meicen Medical Equipment Co., Ltd. · Class I
- Type-S™ Variable Axis Baseplate — Medtec LLC · Class II
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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 813d1dd5-d114-415f-a166-565e3d534848 36 fields · synced Jul 15, 2026
- EUDAMED b1e80c0d-8a0f-4544-8f87-7da9cfa7440f 61 fields · synced Jul 15, 2026