Duns Number:184805166
Device Description: 4.5mm TRIVEX System Resector Kit (blade and tubing)
Catalog Number
7209514
Brand Name
Trivex System
Version/Model Number
7209514
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
K032387
Product Code
DWQ
Product Code Name
Stripper, Vein, External
Public Device Record Key
125cedbc-5940-4949-8163-e74759910711
Public Version Date
April 21, 2021
Public Version Number
4
DI Record Publish Date
July 15, 2015
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 |