Identity
- Trade Name
- MRI-Safe FDA UDI
- Generic Name
- Radiation shielding panel, fixed FDA UDI
- Device Name
- MRI-SAFE CENTER MOUNT OVER HEAD 40X50 SINGLE MOUNT 360 SYSTEM WITHOUT CUTOUT FDA UDI
- Model / Reference
- OS-745RNF FDA UDI
- Description
- MRI-SAFE CENTER MOUNT OVER HEAD 40X50 SINGLE MOUNT 360 SYSTEM WITHOUT CUTOUT FDA UDI
Identifiers
- Catalog Number
- OS-745RNF FDA UDI
- Primary DI / UDI-DI
- 00840348502091 FDA UDI
- FDA Product Code
- IWX FDA UDI
- GMDN Term
- Radiation shielding panel, fixed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation shielding panel, fixed
MRI-Safe by Aadco Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Aadco Medical, Inc.
Sources (1)
- FDA UDI 4bdf1bf4-c820-453f-9d96-e214b93939f8 34 fields · synced Jun 1, 2026