Identity
- Trade Name
- BLOXR FDA UDI
- Generic Name
- Radiation shielding apron FDA UDI
- Device Name
- XPF® Patient Protection Shield, 12" x 14" FDA UDI
- Model / Reference
- 100216 FDA UDI
- Description
- XPF® Patient Protection Shield, 12" x 14" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811042030644 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Radiation shielding apron 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 apron
The Shield, 12" x 14", is a comprehensive patient protection device designed to shield individuals from radiation exposure during medical procedures. It features a durable, fluid-resistant outer covering surrounding a thin sheet of lead or hydrogenous materials for neutron attenuation.
Similar devices
Also classified as Radiation shielding apron.
- K303 — BURLINGTON MEDICAL, LLC · Class I
- Palmero Healthcare, LLC — PALMERO HEALTHCARE LLC · Class I
- FVEST — BURLINGTON MEDICAL, LLC · Class I
- THYROID SHIELD — BURLINGTON MEDICAL, LLC · Class I
- BLOCKER — BURLINGTON MEDICAL, LLC · Class I
- THYROID SHIELD — BURLINGTON MEDICAL, LLC · Class I
- Euro — BURLINGTON MEDICAL, LLC · Class I
- Fast Wrap Apron — Shielding International Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BLOXR Solutions LLC
Sources (1)
- FDA UDI e3d6e104-2abc-499d-a2ec-0b998840339a 33 fields · synced Jul 12, 2026