Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
81617
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
KDC
Product Code Name
INSTRUMENT, SURGICAL, DISPOSABLE
Public Device Record Key
c2179b51-6b89-4d47-84b4-0c2e3f2cf95f
Public Version Date
December 02, 2020
Public Version Number
1
DI Record Publish Date
November 24, 2020
Package DI Number
20809160296148
Quantity per Package
500
Contains DI Package
10809160296141
Package Discontinue Date
-
Package Status
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 |