FDA UDI
In Commercial Distribution
🇺🇸 United States
VIAL SHIELD
DI: 00718175008478
·
Model: 053-610
·
BIODEX MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VIAL SHIELD
- Primary DI
- 00718175008478
- Version / Model
- 053-610
- Catalog Number
- 053-610
- Company Name
- BIODEX MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 043833813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-13
- Public Version
- 1
- Public Version Date
- 2020-04-21
- Public Version Status
- New
- Public Device Record Key
- 5aceaf4b-5187-4d8f-a390-6c81847d2af9
Device Description
Shield, Vial, 0.31" lead, Magnetic Cap
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IWW | Shield, Vial | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38380 | Vial radiation shield | A device, sometimes called a vial holder, designed to partially or completely surround a vial or a container of a solid or liquid radioactive material. It protects persons from unnecessary radiation exposure by partially or totally blocking the radiation emissions from a vial or similar container holding a radiopharmaceutical or other radioactive material used in diagnostic or therapeutic procedures. It is made of lead (Pb) or lead-equivalent materials, the shielding properties may vary depending on the isotopes they are intended to be used with. Some include an opening that allows needle access to the vial contents and some are either totally transparent or include a window. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175008478 | GS1 |