FDA UDI
In Commercial Distribution
🇺🇸 United States
LEAD LINED
DI: 00718175002674
·
Model: 244-151
·
BIODEX MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LEAD LINED
- Primary DI
- 00718175002674
- Version / Model
- 244-151
- Catalog Number
- 244-151
- Company Name
- BIODEX MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 043833813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-15
- Public Version
- 1
- Public Version Date
- 2018-12-17
- Public Version Status
- New
- Public Device Record Key
- 76e458f2-4edc-40d7-8dcc-738a865aa39c
Device Description
Cabinet, Waste, 0.5" Lead
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 40905 | Radiation shielding container, general-purpose | A radiation protection device intended for hospital or clinic use that is specifically designed to shield persons from unintended radiation exposure to radioactive materials, sources, devices, and/or radiopharmaceuticals that are being kept in the facility. The design typically incorporates lead shielding or plastic materials of sufficient thickness to attenuate a specified level of radioactivity. This GMDN code does not include special purpose containers designed as vial or syringe shields or transportation/transfer containers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175002674 | GS1 |