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FlexLock™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4800-FSModel SBRT Devices
by Qfix
Identity
- Trade Name
- FlexLock™ FDA UDI
- Generic Name
- Radiological general body-part positioner FDA UDI
- Device Name
- FlexLock™ Foot Support FDA UDI
- Model / Reference
- RT-4800-FS EUDAMEDFDA UDISBRT Devices EUDAMED
- Description
- FlexLock™ Foot Support FDA UDI
Identifiers
- Catalog Number
- RT-4800-FS FDA UDI
- Primary DI / UDI-DI
- 10841962111086 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621SBRT8G EUDAMED
- FDA Product Code
- JAI FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological general body-part positioner 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Radiological general body-part positioner
FlexLock™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiological general body-part positioner.
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- Oakworks Medical — OAKWORKS, INC. · 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 ee0f7f85-bad0-48fd-abae-83e313d11fe4 35 fields · synced Jun 19, 2026
- EUDAMED 9d936d4b-40cf-436a-b7e4-5f34cac171c0 61 fields · synced Jun 19, 2026