Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
100MI-VLR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 04, 2019
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
KDC
Product Code Name
INSTRUMENT, SURGICAL, DISPOSABLE
Public Device Record Key
b930a405-da92-4de2-aa28-d475e170b230
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
August 20, 2016
Package DI Number
20809160025564
Quantity per Package
50
Contains DI Package
10809160025567
Package Discontinue Date
January 04, 2019
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 |