Duns Number:020417380
Device Description: X-ray apron lead-fre adult without color blue
Catalog Number
1020371
Brand Name
Safco lead-free x-ray aprons
Version/Model Number
1020371
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
For Single-Use
Yes
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
IWO
Product Code Name
Apron, protective
Public Device Record Key
44805b04-7ff6-44cb-afa5-3e77d2d6e174
Public Version Date
September 16, 2020
Public Version Number
1
DI Record Publish Date
September 08, 2020
Package DI Number
D72310203713
Quantity per Package
3
Contains DI Package
D7231020371
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 600 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |