Duns Number:621134084
Device Description: Barrier Flex Vest and Skirt radiation protection apron has an elastic back that provides g Barrier Flex Vest and Skirt radiation protection apron has an elastic back that provides greater comfort, adjustment and support especially during long procedures. Even weight distribution helps reduce body fatigue and shoulder pads provide additional comfort. Optional elastic insert in skirt affords a more comfortable fit.
Catalog Number
-
Brand Name
Barrier Flex Radiation Protection Apron Vest & Skirt-Pb Free-X-Large
Version/Model Number
BFVS-PbF-XL
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"
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For Single-Use
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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
5afaf6f8-251c-49c9-b935-c4d09ed98721
Public Version Date
October 14, 2022
Public Version Number
1
DI Record Publish Date
October 06, 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 |