Identity
- Trade Name
- Freedom Basic Overlay EUDAMEDFreedom FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Freedom Basic CT/ Treatment Overlay (MR Conditional) EUDAMEDFreedom Basic CT/Treatment Overlay (MR Conditional) FDA UDI
- Model / Reference
- LB02-K EUDAMED1 FDA UDI
- Description
- Freedom Basic CT/Treatment Overlay (MR Conditional) FDA UDI
Identifiers
- Catalog Number
- LB02-K FDA UDI
- Primary DI / UDI-DI
- 00628341930086 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193168Q 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
Similar devices
Also classified as Indexed-immobilization patient positioning system.
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- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- DSPS® Cradle-S H MR — MACROMEDICS B.V. · Class II
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- IPPS™ Overlay — Medtec LLC · Class II
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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 09a8e07a-a0e8-4bdf-9311-f96cc2124242 36 fields · synced Jul 11, 2026
- EUDAMED ecad7dbd-061d-4c80-a1ad-988cb2f81baa 61 fields · synced Jul 11, 2026