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
Primary Device ID10844735006176
NIH Device Record Key9eaac3f0-9774-4ecc-8322-3887ce651b30
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM VESSEL EVERTER
Version Model NumberGEM2742
Catalog Number519600001061
Company DUNS031284586
Company NameSYNOVIS MICRO COMPANIES ALLIANCE, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844735006179 [Primary]
GS110844735006176 [Package]
Contains: 00844735006179
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVRDevice, anastomotic, microvascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-18
Device Publish Date2019-10-30

Devices Manufactured by SYNOVIS MICRO COMPANIES ALLIANCE, INC

00844735006728 - DERMACLOSE2024-07-05 DERMACLOSE (66CM) US-APAC
00844735006735 - DERMACLOSE2024-07-05 DERMACLOSE (95CM) US-APAC
10844735006237 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.
10844735006244 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
10844735006251 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
10844735006268 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
10844735006275 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins
10844735006282 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

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