Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
4010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K003002,K003002
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
4e111ad3-6640-49e4-bf65-91a681392fcf
Public Version Date
November 08, 2018
Public Version Number
4
DI Record Publish Date
August 20, 2016
Package DI Number
20809160002541
Quantity per Package
48
Contains DI Package
10809160002544
Package Discontinue Date
November 02, 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 |