Duns Number:809784593
Device Description: CVT GENTLECATH IC CATH INSERT SUPPLIES KIT
Catalog Number
503870
Brand Name
GENTLECATH
Version/Model Number
503870
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2022
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
K010420,K010420
Product Code
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
e9c42fc0-ce43-474c-84ce-c6af6b8ff63f
Public Version Date
May 23, 2022
Public Version Number
5
DI Record Publish Date
September 09, 2016
Package DI Number
94026704582269
Quantity per Package
100
Contains DI Package
04026704582266
Package Discontinue Date
May 20, 2022
Package Status
Not 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 |