GEM VESSEL EVERTER 519600001061

GUDID 10844735006176

The VESSEL EVERTER System is used with the GEM COUPLER and Flow COUPLER Device to press vessel tissue onto the GEM Flow COUPLER/COUPLER rings, and to measure the vessel, if needed.

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use Vascular anastomosis coupling kit, single-use

• Primary Device ID: 10844735006176
• NIH Device Record Key: 9eaac3f0-9774-4ecc-8322-3887ce651b30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM VESSEL EVERTER
• Version Model Number: GEM2742
• Catalog Number: 519600001061
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735006179 [Primary]
GS1	10844735006176 [Package]; Contains: 00844735006179; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190499

FDA Product Code

• MVR: Device, anastomotic, microvascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-18
• Device Publish Date: 2019-10-30

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• 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.