Identity
- Trade Name
- Elution Test Vial Shield FDA UDI
- Generic Name
- Vial radiation shield FDA UDI
- Device Name
- Elution Test Vial Shield for use with CardioGen-82 Infusion System FDA UDI
- Model / Reference
- 001550 FDA UDI
- Description
- Elution Test Vial Shield for use with CardioGen-82 Infusion System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30815112021383 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Vial radiation shield
Elution Test Vial Shield by Bracco Diagnostics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vial radiation shield.
- PET VIAL SHIELD — Biodex Medical Systems · Class I
- VIAL SHIELD — Biodex Medical Systems · Class I
- VIAL SHIELD — Biodex Medical Systems · Class I
- VIAL SHIELD — Biodex Medical Systems · Class I
- HIGH DENSITY LEAD GLASS VIAL SHIELD — Biodex Medical Systems · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- SIR-Spheres V-Vial Holder — SIRTEX MEDICAL PTY LTD · Class I
- SIROS D-Vial Prep Set — SIRTEX MEDICAL PTY LTD · 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
- Bracco Diagnostics Inc.
Sources (1)
- FDA UDI 452574d8-7655-46d0-8e4e-b751499c581a 34 fields · synced May 31, 2026