Sabella Flex
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SaBella Flex (MR Conditional) EUDAMEDSabella Flex FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- SaBella Flex Dual Axis Precision Positioning Overlay Only (MR Conditional) EUDAMEDFDA UDI
- Model / Reference
- SBS14 MR Conditional SaBella Flex Series EUDAMEDSBS14-K Series EUDAMED1 FDA UDI
- Description
- SaBella Flex Dual Axis Precision Positioning Overlay Only (MR Conditional) FDA UDI
Identifiers
- Catalog Number
- SBS14-K FDA UDI
- Primary DI / UDI-DI
- 00628341930260 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193318L EUDAMED
- 510(k) Number
- K122888 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Indexed-immobilization patient positioning system
Sabella Flex by CDR Systems Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indexed-immobilization patient positioning system.
- QUANTUM™ CT Overlay — Qfix · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- DSPS® Cradle-S H MR — MACROMEDICS B.V. · Class II
- FlexBoard™ BTM-SX — MACROMEDICS B.V. · Class II
- IPPS™ Overlay — Medtec LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
Cleared under the same submission
K122888 also covers:
- Extremity Lock — CDR Systems Inc
- Extremity Lock — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
- Freedom — CDR Systems Inc
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CDR Systems Inc
Sources (2)
- FDA UDI f4169250-11e2-433b-8f92-25507f99d5a5 36 fields · synced Jul 19, 2026
- EUDAMED b35303d3-26bf-4303-a1ef-21e782f401f7 61 fields · synced Jul 19, 2026