GEM COUPLER Microvascular Anastomotic Instrument 519303002010

GUDID 00844735005233

A reusable Instrument designed to hold the GEM COUPLER device and approximate the GEM COUPLER rings during vessel anastomosis

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator Vascular anastomosis coupling approximator

• Primary Device ID: 00844735005233
• NIH Device Record Key: a1b816b2-f50a-4d44-a995-5eb14ba01141
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM COUPLER Microvascular Anastomotic Instrument
• Version Model Number: GEM2740
• Catalog Number: 519303002010
• Company DUNS: 031284586
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
• Email: smca_information@baxter.com
• Phone: +1(800)510-3318
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Operating and Storage Conditions

• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735005233 [Primary]
GS1	00844735006674 [Direct Marking]

FDA Product Code

• MDM: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

[00844735005233]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by SYNOVIS MICRO COMPANIES ALLIANCE, INC

• 10844735006237 - GEM BIOVER Microvascular Clamp: 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.
• 10844735006244 - GEM BIOVER Microvascular Clamp: 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
• 10844735006251 - GEM BIOVER Microvascular Clamp: 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
• 10844735006268 - GEM BIOVER Microvascular Clamp: 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
• 10844735006275 - GEM BIOVER Microvascular Clamp: 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
• 10844735006282 - GEM BIOVER Microvascular Clamp: 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
• 10844735006299 - GEM BIOVER Microvascular Clamp: 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.
• 10844735006305 - GEM BIOVER Microvascular Clamp: 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.