Duns Number:031284586
Device Description: The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene and surgic The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable. The GEM Microvascular Anastomotic COUPLER Device is single-use and available in various sizes
Catalog Number
512100400060
Brand Name
GEM Microvascular Anastomotic COUPLER
Version/Model Number
GEM2756
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
21c793d0-7484-4f7d-8a12-8a0348cb9d6f
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
October 08, 2015
Package DI Number
10844735002727
Quantity per Package
6
Contains DI Package
00844735002720
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 |