Identity
- Trade Name
- VIAL SHIELD FDA UDI
- Generic Name
- Vial radiation shield FDA UDI
- Device Name
- Shield, Vial, 0.31" lead, Magnetic Cap FDA UDI
- Model / Reference
- 053-610 FDA UDI
- Description
- Shield, Vial, 0.31" lead, Magnetic Cap FDA UDI
Identifiers
- Catalog Number
- 053-610 FDA UDI
- Primary DI / UDI-DI
- 00718175008478 FDA UDI
- FDA Product Code
- IWW FDA UDI
- GMDN Term
- Vial radiation shield 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vial radiation shield
Vial Shield by Biodex Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vial radiation shield.
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Elution Test Vial Shield — Bracco Diagnostics Inc. · Class I
- Elution Test Vial Shield — Bracco Diagnostics Inc. · Class I
- PET VIAL SHIELD — Biodex Medical Systems · Class I
- VIAL SHIELD — Biodex Medical Systems · 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
- Biodex Medical Systems
Sources (1)
- FDA UDI 5aceaf4b-5187-4d8f-a390-6c81847d2af9 34 fields · synced Jun 1, 2026