Identity
- Trade Name
- UniRay FDA UDI
- Generic Name
- Patient radiation shielding pad/drape, single-use FDA UDI
- Device Name
- RadBlock Radial Entry (Medium) FDA UDI
- Model / Reference
- UFD42B09 FDA UDI
- Description
- RadBlock Radial Entry (Medium) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904333240497 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Patient radiation shielding pad/drape, single-use 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Patient radiation shielding pad/drape, single-use
UniRay by Uniray Medical Llp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient radiation shielding pad/drape, single-use.
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- RADPAD — Worldwide Innovations & Technologies, Inc. · Class II
- Halyard Scatter Radiation Shields — ANGIOSYSTEMS, INCORPORATED · Class I
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- SecureShield© Multipurpose 12" x 36" Scatter Reducing Drape — BARRIER TECHNOLOGIES, LLC · Class I
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
- Uniray Medical Llp
Sources (1)
- FDA UDI ed39cb30-6029-40ca-9122-bc5319c35044 33 fields · synced May 30, 2026