Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
76913
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 18, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDD
Product Code Name
Kit, surgical instrument, disposable
Public Device Record Key
26f3476f-8bd4-463b-9dfd-32dd2234d4df
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
January 30, 2018
Package DI Number
20809160177553
Quantity per Package
20
Contains DI Package
10809160177556
Package Discontinue Date
June 18, 2018
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 |