Duns Number:621134084
Device Description: Standard Vest and Skirt radiation protection apron provides maximum protection and freedom Standard Vest and Skirt radiation protection apron provides maximum protection and freedom of movement and is an ideal choice for long procedures. Even weight distribution helps reduce body fatigue and an optional elastic insert in the skirt affords a more comfortable fit. Shoulder pads provide additional comfort.
Catalog Number
-
Brand Name
Standard Vest & Skirt Radiation Protection Apron - Pb Standard - XX-Large
Version/Model Number
SVS-PbS-XXL
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
dd92a021-72a5-4aff-8780-230912f65c35
Public Version Date
October 21, 2022
Public Version Number
1
DI Record Publish Date
October 13, 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 |