GEM Microvascular Anastomotic COUPLER Sterilization Tray 519302003010

GUDID 00844735002829

A highly perforated, reusable, single tier sterilization tray, consisting of an anodized aluminum base and cover with instrument holder bars

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Sterilization/disinfection container

• Primary Device ID: 00844735002829
• NIH Device Record Key: 08d4e8ac-a90b-4810-9ec6-b1f736946f24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM Microvascular Anastomotic COUPLER Sterilization Tray
• Version Model Number: GEM 2745
• Catalog Number: 519302003010
• Company DUNS: 031284586
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735002829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071783

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

[00844735002829]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-10
• Device Publish Date: 2016-09-24

Devices Manufactured by SYNOVIS MICRO COMPANIES ALLIANCE, INC

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• 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