Identity
- Trade Name
- Freedom 6 Couch Extension EUDAMEDFreedom FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Freedom 6 Couch Extension Head & Neck EUDAMEDFDA UDI
- Model / Reference
- SB02 EUDAMED1 FDA UDI
- Description
- Freedom 6 Couch Extension Head & Neck FDA UDI
Identifiers
- Catalog Number
- SB02 FDA UDI
- Primary DI / UDI-DI
- 00628341930178 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193198W 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
Freedom by CDR Systems Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (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 161c86fa-d8a8-492d-bc12-def071d2b415 36 fields · synced Jul 15, 2026
- EUDAMED f7145047-62c6-44bf-aed1-671adef0653c 61 fields · synced Jul 15, 2026