GEM Microvascular Anastomotic COUPLER System 519301006010

GUDID 00844735005226

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.

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Vascular anastomosis coupling kit, reusable
Primary Device ID00844735005226
NIH Device Record Key62e5fae7-e47d-4004-8735-1686ac4e165c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM Microvascular Anastomotic COUPLER System
Version Model NumberGEM 2741CC
Catalog Number519301006010
Company DUNS031284586
Company NameSYNOVIS MICRO COMPANIES ALLIANCE, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com
Phone+1(800)510-3318
Emailsmca_information@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844735005226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


[00844735005226]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-24

Devices Manufactured by SYNOVIS MICRO COMPANIES ALLIANCE, INC

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10844735006237 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.
10844735006244 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
10844735006251 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
10844735006268 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
10844735006275 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
10844735006282 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

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