GEM COUPLER Forceps 519306001010

GUDID 00844735002850

Reusable instrument used to grasp the blood vessel and evert onto the GEM COUPLER rings.

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Vascular anastomosis coupling forceps Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Primary Device ID00844735002850
NIH Device Record Keya68f8943-1c05-4389-9798-00e91780943e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM COUPLER Forceps
Version Model NumberGEM4183C
Catalog Number519306001010
Company DUNS031284586
Company NameSYNOVIS MICRO COMPANIES ALLIANCE, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100844735002850 [Primary]
GS100844735006698 [Direct Marking]

FDA Product Code

HTDFORCEPS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


[00844735002850]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by SYNOVIS MICRO COMPANIES ALLIANCE, INC

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
10844735006299 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.
10844735006305 - GEM BIOVER Microvascular Clamp2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.

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