Identity
- Trade Name
- High Density Lead Glass, Syringe Shield FDA UDI
- Generic Name
- Syringe radiation shield FDA UDI
- Device Name
- High Density Lead Glass, Syringe Shield, 10cc and 12cc. Accommodates Luer and Non-Luer Lock Syringes. FDA UDI
- Model / Reference
- 007-612 FDA UDI
- Description
- High Density Lead Glass, Syringe Shield, 10cc and 12cc. Accommodates Luer and Non-Luer Lock Syringes. FDA UDI
Identifiers
- Catalog Number
- 007-612 FDA UDI
- Primary DI / UDI-DI
- 00718175006122 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Syringe 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: Syringe radiation shield
High Density Lead Glass, Syringe Shield by Biodex Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 71d74970-789a-4c4e-8f62-01c9b6360e84 34 fields · synced May 30, 2026