Identity
- Trade Name
- STAND DOSE PREP FDA UDI
- Generic Name
- Radiation shielding container, general-purpose FDA UDI
- Device Name
- Stand, Dose Preparation FDA UDI
- Model / Reference
- 042-455 FDA UDI
- Description
- Stand, Dose Preparation FDA UDI
Identifiers
- Catalog Number
- 042-455 FDA UDI
- Primary DI / UDI-DI
- 00718175004555 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Radiation shielding container, general-purpose 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: Radiation shielding container, general-purpose
Stand Dose Prep by Biodex Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LEAD LINED — Biodex Medical Systems · Class I
- LEAD LINED — Biodex Medical Systems · Class I
- LEAD LINED — 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 04c56e15-46f4-405b-a912-6f1432f6255a 34 fields · synced Jun 1, 2026