Identity
- Trade Name
- Steradian Shield FDA UDI
- Generic Name
- Radiation shielding panel, portable/mobile FDA UDI
- Device Name
- Radiation Protection Shield FDA UDI
- Model / Reference
- SS0100 FDA UDI
- Description
- Radiation Protection Shield FDA UDI
Identifiers
- Catalog Number
- SS0100 FDA UDI
- Primary DI / UDI-DI
- 00853714008035 FDA UDI
- FDA Product Code
- EAK FDA UDI
- GMDN Term
- Radiation shielding panel, portable/mobile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Steradian Shield by Radux Devices, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radux Devices, Inc
Sources (1)
- FDA UDI 6e8afc56-5042-4293-9eaa-0d1cd835ea51 36 fields · synced May 30, 2026