FDA UDI
In Commercial Distribution
🇺🇸 United States
RADPAD
DI: 00852814003346
·
Model: 5700-Y-NS
·
WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RADPAD
- Primary DI
- 00852814003346
- Version / Model
- 5700-Y-NS
- Company Name
- WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.
- Labeler DUNS
- 121621853
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-19
- Public Version
- 3
- Public Version Date
- 2020-07-22
- Public Version Status
- Update
- Public Device Record Key
- d7e9d74a-d41d-4532-ad8f-da360a8a75d4
Device Description
Infant Collimation Shield-Non-Sterile 4 pack-Yellow
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| 64315 | Multiple Babesia species nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple species of the Babesia protozoa (e.g., B. microti, B. duncani, B. divergens and B. venatorum) in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10852814003343 | GS1 | 15 | In Commercial Distribution | ||
| Primary | 00852814003346 | GS1 |