Duns Number:031284586
Device Description: The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene and surgic
Catalog Number
511100100060
Brand Name
GEM Microvascular Anastomotic COUPLER
Version/Model Number
GEM2750
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
MVR
Product Code Name
Device,anastomotic,microvascular
Public Device Record Key
a1f097e5-d48b-468b-91dc-728b52e0595a
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
October 08, 2015
Package DI Number
10844735002604
Quantity per Package
6
Contains DI Package
00844735002607
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 |