Duns Number:828918164
Device Description: MTG Jiffy Cath Closed systems 14fr pre-lubricated urinary catheter with PvP
Catalog Number
21114
Brand Name
MTG
Version/Model Number
21114
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080878,K080878
Product Code
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
ebed5010-fb05-47f5-9818-2500d2fb49f4
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
50850025153664
Quantity per Package
100
Contains DI Package
00850025153669
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |