Duns Number:621134084
Device Description: Barrier Wrap with Support Apron. Provides full wrap around protection against direct & sc Barrier Wrap with Support Apron. Provides full wrap around protection against direct & scatter radiation. One-piece desgin enables easy-on & easy-off. Fully adjustable integrated back support belt provides maximum support to the lower lumbar region. UltraFlex material. Black color. Size small. Thyroid collar included.
Catalog Number
-
Brand Name
BARRIER WRAP W/SUPPORT W/TC ULTRAFLEX/BLK/SM
Version/Model Number
BWSP-.5mmPbF-SM-UF-BLK
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EAJ
Product Code Name
Apron, Leaded
Public Device Record Key
9b6c50e5-db3f-41ae-b40e-9e259e01bd71
Public Version Date
August 10, 2022
Public Version Number
1
DI Record Publish Date
August 02, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 107 |