Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
750069
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 18, 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
MNL
Product Code Name
ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Public Device Record Key
eef3febc-be9a-4016-acdb-886349bd153f
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
February 23, 2017
Package DI Number
30809160129801
Quantity per Package
10
Contains DI Package
20809160129804
Package Discontinue Date
November 18, 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 |