FDA UDI
In Commercial Distribution
🇺🇸 United States
KENEX
DI: 05055449407298
·
Model: 312/W-LB
·
KENEX (ELECTRO-MEDICAL) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KENEX
- Primary DI
- 05055449407298
- Version / Model
- 312/W-LB
- Catalog Number
- 312/W-LB
- Company Name
- KENEX (ELECTRO-MEDICAL) LIMITED
- Labeler DUNS
- 217421064
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-30
- Public Version
- 2
- Public Version Date
- 2024-01-31
- Public Version Status
- Update
- Public Device Record Key
- 68e32f11-6e83-451c-b257-55fb5af93ad8
Device Description
Wall Rack for lower body table shields
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 38368 | Radiation shielding apron rack | A device intended to store a radiation shielding apron used for radiation protection in a manner that protects it from damage, e.g., through folding, and preserves its inherent shielding capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055449407298 | GS1 |