DEVICE: GEM Microvascular Anastomotic COUPLER System (00844735005226)
Device Identifier (DI) Information
GEM Microvascular Anastomotic COUPLER System
GEM 2741CC
In Commercial Distribution
519301006010
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM 2741CC
In Commercial Distribution
519301006010
SYNOVIS MICRO COMPANIES ALLIANCE, INC
The GEM Microvascular Anastomotic COUPLER System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, and reusable Microvascular Anastomotic COUPLER Sterilization Tray.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61239 | Vascular anastomosis coupling kit, reusable |
A collection of devices intended to be used to implant a vascular anastomosis coupler [not included] to join vascular (including microvascular) structures by the coupling of two ring-shaped components. It consists of two or more items typically amongst: a coupling approximator for holding the rings of the coupler during approximation, a dedicated forceps/everter for placing the ends of the blood vessel over the pins of the coupler, a vessel diameter guide (sizer), and a sterilization tray. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KCT | Sterilization wrap containers, trays, cassettes & other accessories |
MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
HTD | FORCEPS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K071783 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 20 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
62e5fae7-e47d-4004-8735-1686ac4e165c
July 27, 2023
8
September 24, 2016
July 27, 2023
8
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)510-3318
smca_information@baxter.com
smca_information@baxter.com