Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
708-BSW
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 13, 2022
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
44f28466-49ae-4bf9-ad4c-8ba4e5d819dc
Public Version Date
October 17, 2022
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
50809160000524
Quantity per Package
10
Contains DI Package
10809160000526
Package Discontinue Date
October 13, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |