Duns Number:184805166
Device Description: Latis Silicone Graft Cleaning Catheter
Catalog Number
A4G02
Brand Name
Latis Silicone Graft Cleaning Catheter
Version/Model Number
A4G02
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
K973465
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
8d33928a-0a26-4f58-8dee-1adaa45ba55f
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
June 18, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 453 |
3 | A medical device with high risk that requires premarket approval | 22 |