Duns Number:020417380
Device Description: Xray apron lead-free adult with collar beige
Catalog Number
1020386
Brand Name
Safco lead-free x-ray aprons
Version/Model Number
1020386
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
7dccad4d-166d-4199-9cda-55d2b2cbfa4e
Public Version Date
September 16, 2020
Public Version Number
1
DI Record Publish Date
September 08, 2020
Package DI Number
D72310203863
Quantity per Package
3
Contains DI Package
D7231020386
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 |