Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
235
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 09, 2020
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
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
5b033c7a-7398-43aa-a7ee-81f3372a5d50
Public Version Date
September 10, 2020
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
30809160004115
Quantity per Package
8
Contains DI Package
20809160004118
Package Discontinue Date
September 09, 2020
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 |