Duns Number:031284586
Device Description: The VESSEL EVERTER System is used with the GEM COUPLER and Flow COUPLER Device to press ve The VESSEL EVERTER System is used with the GEM COUPLER and Flow COUPLER Device to press vessel tissue onto the GEM Flow COUPLER/COUPLER rings, and to measure the vessel, if needed.
Catalog Number
519600001061
Brand Name
GEM VESSEL EVERTER
Version/Model Number
GEM2742
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"
Yes
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
K190499,K190499
Product Code
MVR
Product Code Name
Device, anastomotic, microvascular
Public Device Record Key
9eaac3f0-9774-4ecc-8322-3887ce651b30
Public Version Date
October 11, 2022
Public Version Number
5
DI Record Publish Date
October 30, 2019
Package DI Number
10844735006176
Quantity per Package
6
Contains DI Package
00844735006179
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |