Duns Number:621134084
Device Description: The Standard Vest and Skirt radiation protection apron provides maximum protection and fre The 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 and shoulder pads provide a more comfortable fit.
Catalog Number
-
Brand Name
Standard Vest & Skirt Radiation Protection Apron - Pb Free - Medium
Version/Model Number
SVS-PbF-MD
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
cd170933-d70c-413a-b452-20d40e38246e
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 |