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 Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable Vascular anastomosis coupling kit, reusable

• Primary Device ID: 00844735005226
• NIH Device Record Key: 62e5fae7-e47d-4004-8735-1686ac4e165c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM Microvascular Anastomotic COUPLER System
• Version Model Number: GEM 2741CC
• Catalog Number: 519301006010
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735005226 [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

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-24

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