Duns Number:809784593
Device Description: GENTLECATH LOWFRIC TMNN CH18
Catalog Number
-
Brand Name
GENTLECATH
Version/Model Number
421912
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
-
Product Code
GBM
Product Code Name
Catheter, Urethral
Public Device Record Key
230685ed-c8f5-41d7-bcf1-3f03a2721b22
Public Version Date
October 20, 2022
Public Version Number
7
DI Record Publish Date
February 22, 2019
Package DI Number
70768455153847
Quantity per Package
8
Contains DI Package
50768455153843
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 | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 116 |
U | Unclassified | 8 |