Duns Number:621134084
Device Description: Support Vest and Skirt Apron. Maximum freedom of movement with full front and back protec Support Vest and Skirt Apron. Maximum freedom of movement with full front and back protection against direct & scatter radiation. Even weight distribution helps reduce body fatigue. Elastic insert in skirt affords a more comfortable fit. Fully adjustable integrated back support belt provides maximum support to the lower lumbar region.
Catalog Number
-
Brand Name
Support Vest & Skirt Radiation Protection Apron - Pb Standard - XX-Large
Version/Model Number
SPVS-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
8149d117-e285-499b-9dae-fba54395ac29
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 |