Duns Number:621134084
Device Description: The Basic with Buckle radiation protection apron is our most economically priced frontal a The Basic with Buckle radiation protection apron is our most economically priced frontal apron. 2” Buckle with Velcro shoulder strap to keep apron snug.
Catalog Number
-
Brand Name
The Basic with Buckle radiation protection Apron-PbFree-Medium
Version/Model Number
TBB-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
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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
67600871-8cad-4a26-84f2-9f27a78ccbda
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 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 |