Duns Number:621134084
Device Description: The Barrier Flex provides excellent weight distribution and comfort. Two full adjustable V The Barrier Flex provides excellent weight distribution and comfort. Two full adjustable Velcro straps cross in the back and attach in the front providing a comfortable fit while keeping the apron securely on the shoulders. Adjustable elastic inserts in the rear flaps offer greater comfort, adjustment and support. Comfortable fit during long procedures. Shoulder pads provide additional comfort.
Catalog Number
-
Brand Name
Barrier Flex Radiation Protection Apron - Pb Standard - X-Large
Version/Model Number
BF-PbS-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
-
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
7573fa3e-e854-42a9-b549-2271ef158037
Public Version Date
October 20, 2022
Public Version Number
1
DI Record Publish Date
October 12, 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 |