Identity
- Trade Name
- Mediclic HE FDA UDI
- Generic Name
- Syringe radiation shield FDA UDI
- Model / Reference
- 5 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701430100113 FDA UDI
- FDA Product Code
- IWR 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
Yes
FDA UDI
Category: Syringe radiation shield
Mediclic HE by Lemer Pax — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Syringe radiation shield.
- Pro-Tec Pet Syringe Shield — Biodex Medical Systems · Class I
- Pro-Tec IV Syringe Shield — Biodex Medical Systems · Class I
- Z-Pet, Syringe Shield — Biodex Medical Systems · Class I
- Pro-Tec Pet Syringe Shield — Biodex Medical Systems · Class I
- Pro-Tec III Syringe Shield — Biodex Medical Systems · Class I
- Pro-Tec III Syringe Shield — Biodex Medical Systems · Class I
- Pro-Tec III Syringe Shield — Biodex Medical Systems · Class I
- Pet / MR Pro-Tec, Syringe 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lemer Pax
Sources (1)
- FDA UDI 8fa313bd-3723-46c6-a8f4-7d8dbb8e9a96 32 fields · synced May 30, 2026