Identity
- Trade Name
- Sabella Flex FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- SaBella Flex Dual Axis Precision Positioning Overlay Only FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- SaBella Flex Dual Axis Precision Positioning Overlay Only FDA UDI
Identifiers
- Catalog Number
- SBS14 FDA UDI
- Primary DI / UDI-DI
- 00628341930253 FDA UDI
- 510(k) Number
- K122888 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Indexed-immobilization patient positioning system 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Indexed-immobilization patient positioning system
Sabella Flex by CDR Systems Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CDR Systems Inc
Sources (1)
- FDA UDI 23c9ed5b-f0d5-45b8-aa7e-223c19bdd0c3 36 fields · synced Jun 8, 2026