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 design enables easy-on & easy-off. Fully adjustable integrated back support belt provides maximum support to the lower lumbar region. UltraFlex material. Teal. Size Medium. Thyroid Collar included.
Catalog Number
-
Brand Name
BARRIER WRAP W/SUPPORT W/TC ULTRAFLEX/TEAL/MD
Version/Model Number
BWSP-.5mmPbF-MD-UF-TEAL
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
b53ae7c1-67f4-4f63-be7c-0b8b2df7b93a
Public Version Date
August 11, 2022
Public Version Number
1
DI Record Publish Date
August 03, 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 |