Duns Number:011005491
Device Description: Pre-Lubricated Closed System Intermittent Catheter
Catalog Number
-
Brand Name
MTG EZ-Advancer® Mini-Pak
Version/Model Number
40112
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"
-
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
K080878,K080878,K080878
Product Code
KOD
Product Code Name
Catheter, Urological
Public Device Record Key
2a0f2d9e-b03b-4142-8caa-fb43936cfff2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 13, 2016
Package DI Number
10892673002552
Quantity per Package
4
Contains DI Package
20892673002979
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 121 |