FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SHIELDED DECAY DRUM
DI: 00718175002872
·
Model: 039-287
·
BIODEX MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SHIELDED DECAY DRUM
- Primary DI
- 00718175002872
- Version / Model
- 039-287
- Catalog Number
- 039-287
- Company Name
- BIODEX MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 043833813
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-31
- Public Version
- 3
- Public Version Date
- 2026-02-19
- Public Version Status
- Update
- Public Device Record Key
- 8f11e4f6-0ac7-4904-8890-1d8f2d6ff337
- Distribution End Date
- 2023-04-01
Device Description
Drum, Decay, Shielded, .125" Lead , 30 Gallon Plastic Liner
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 |
|---|---|---|---|---|
| KPY | Shield, Protective, Personnel | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35430 | Radioactive waste container | A hard-walled container designed for the safe deposit, collection and storage of radioactive materials including containers previously used for those materials (e.g., scintillation vials). It is made from metal and/or hard plastic and typically designed with an internal radiation shield [e.g., a lead (Pb) liner]. It typically has a lid with radiation shielding properties that allows temporary and final closure options. It is identified with a radioactive symbol on its labelling and sent to a radioactive waste treatment plant for disposal when filled to the recommended level. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175002872 | GS1 |