Identity
- Trade Name
- Back Relief Apron FDA UDI
- Generic Name
- Radiation shielding apron FDA UDI
- Device Name
- Back Relief Apron X-Small - 0.5mm Regular Lead (RL) FDA UDI
- Model / Reference
- BRXSLF FDA UDI
- Description
- Back Relief Apron X-Small - 0.5mm Regular Lead (RL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- G031BRXSLF0 FDA UDI
- FDA Product Code
- IWO 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Radiation shielding apron
The Back Relief Apron X-Small is a radiation shielding apron designed to provide comprehensive protection for individuals undergoing medical procedures, including those in radiology. Made from a durable fluid-resistant outer covering surrounding a thin sheet of lead or lead-equivalent material, this reusable device provides a reliable barrier against neutron and mixed beta-gamma radiation fields.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Shielding International Inc.
Sources (1)
- FDA UDI b5a3eac1-1721-435c-bb7d-c98330b755ec 33 fields · synced Jun 23, 2026