Identity
- Trade Name
- RADPAD FDA UDI
- Generic Name
- Patient radiation shielding pad/drape, single-use FDA UDI
- Device Name
- Biopsy/Biliary Shield-Red FDA UDI
- Model / Reference
- 5510A-R FDA UDI
- Description
- Biopsy/Biliary Shield-Red FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852814003797 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Patient radiation shielding pad/drape, single-use
Radpad by Worldwide Innovations & Technologies, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient radiation shielding pad/drape, single-use.
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- UniRay — UNIRAY MEDICAL LLP · Class I
- Halyard Scatter Radiation Shields — ANGIOSYSTEMS, INCORPORATED · Class I
- Halyard Scatter Radiation Shields — ANGIOSYSTEMS, INCORPORATED · Class I
- UniRay — UNIRAY MEDICAL LLP · Class I
- SecureShield© Multipurpose 12" x 36" Scatter Reducing Drape — BARRIER TECHNOLOGIES, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Worldwide Innovations & Technologies, Inc.
Sources (2)
- FDA UDI a625d19d-b167-4caa-8e3d-b515b9dc0d83 33 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 28, 2026