Duns Number:621134084
Device Description: The Adjustable Flex with Wide Belt radiation protection apron offers even weight distribut The Adjustable Flex with Wide Belt radiation protection apron offers even weight distribution for less stress on the neck and back. 6” fully adjustable wide elastic belt shifts the weight of the apron from the shoulders to the hips. Fully adjustable back saver belt provides maximum support to the lower lumbar region. Velcro shoulder strap helps prevent slippage and shoulder pads provide additional comfort.
Catalog Number
-
Brand Name
Adjustable Flex Wide Belt Radiation Protection Apron-Pb Free-Large
Version/Model Number
AFWB-PbF-LG
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
15ff77a8-c660-4f81-aa78-761b84b0ba6b
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 |