Identity
- Trade Name
- Pro-Tec III Syringe Shield FDA UDI
- Generic Name
- Syringe radiation shield FDA UDI
- Device Name
- Pro-Tec III Syringe Shield, Tungsten 3cc FDA UDI
- Model / Reference
- 007-735 FDA UDI
- Description
- Pro-Tec III Syringe Shield, Tungsten 3cc FDA UDI
Identifiers
- Catalog Number
- 007-735 FDA UDI
- Primary DI / UDI-DI
- 00718175007358 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Syringe radiation shield
Pro-Tec III Syringe Shield by Biodex Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Syringe radiation shield.
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- Easyview LE — LEMER PAX · Class I
- EASYSQUEEZE — LEMER PAX · 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 a338c3f9-f62c-4918-b3b8-4da725bc2ba8 34 fields · synced May 30, 2026