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

• 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
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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
• 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
• 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
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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

• 00844735006728 - DERMACLOSE: 2024-07-05 DERMACLOSE (66CM) US-APAC
• 00844735006735 - DERMACLOSE: 2024-07-05 DERMACLOSE (95CM) US-APAC
• 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