Duns Number:031284586
Device Description: The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two reusable C The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, two MircoClip Appliers and a double tier MicroTray Sterilization Tray.
Catalog Number
519321006011
Brand Name
GEM MICROTRAY MAX
Version/Model Number
GEM2551-2-CS
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
-
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
K071783
Product Code
GDO
Product Code Name
Applier, surgical, clip
Public Device Record Key
6285a36b-fb8b-4f6f-86ec-1d1c059c35cc
Public Version Date
October 19, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |