Identity
- Trade Name
- SHIPPING SYSTEM FDA UDI
- Generic Name
- Radiation shielding container, transport/transfer FDA UDI
- Device Name
- SHIPPING SYSTEM, I-124 VIAL PIG FDA UDI
- Model / Reference
- 001-882 FDA UDI
- Description
- SHIPPING SYSTEM, I-124 VIAL PIG FDA UDI
Identifiers
- Catalog Number
- 001-882 FDA UDI
- Primary DI / UDI-DI
- 00718175001882 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Radiation shielding container, transport/transfer 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, transport/transfer
Shipping System by Biodex Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation shielding container, transport/transfer.
- GammaTile Radiation Shielding Tray — GT Medical Technologies · Class I
- PET UNIT DOSE — Biodex Medical Systems · Class I
- PRO-TEC PIG — Biodex Medical Systems · Class I
- PET SHIPPING SYSTEM — Biodex Medical Systems · Class I
- PRO-TEC PIG — Biodex Medical Systems · Class I
- SHIELDED SYRINGE CARRIERS — Biodex Medical Systems · Class I
- SHIELDED SYRINGE CARRIERS — Biodex Medical Systems · Class I
- SHIPPING SYSTEM — 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 7f1ec40c-f73c-4e96-8a15-ef8893e069aa 34 fields · synced May 30, 2026