FDA.reportPublic FDA data

GEM Microvascular Anastomotic COUPLER

Primary DI
00844735002669
Brand
GEM Microvascular Anastomotic COUPLER
Company
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Model
GEM2753
Catalog number
511100250060
Device description
The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable. The GEM Microvascular Anastomotic COUPLER Device is single-use and available in various sizes
Published
2015-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVRDevice,anastomotic,microvascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVRDevice, Anastomotic, MicrovascularGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10844735002666PackageGS16In Commercial Distribution
00844735002669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084473500266610844735002666
00844735002669008447350026698447350026690844735002669

GMDN Terms#

Term, Definition table
TermDefinition
Vascular anastomosis coupler, basicAn implantable device intended to be used to permanently join vascular structures (blood vessels) through the coupling of two ring-shaped components that are inserted into the ends of the vessels to be attached. It is also used in microvascular surgery. This device is made of a substance or material that cannot be chemically degraded or absorbed via natural body processes (e.g., stainless steel). Some types are preloaded on, or supplied with, disposable devices associated with implantation (e.g., coupling approximator).

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
031284586
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844735006230GEM BIOVER Microvascular ClampTKFV-1TKFV-12022-04-19
00844735006247GEM BIOVER Microvascular ClampTKSV-1TKSV-12022-04-19
00844735006254GEM BIOVER Microvascular ClampTKMV-1TKMV-12022-04-19
00844735006261GEM BIOVER Microvascular ClampTKLV-1TKLV-12022-04-19
00844735006278GEM BIOVER Microvascular ClampTKS-1TKS-12022-04-19
00844735006285GEM BIOVER Microvascular ClampTKM-1TKM-12022-04-19
00844735006292GEM BIOVER Microvascular ClampTKL-1TKL-12022-04-19
00844735006308GEM BIOVER Microvascular ClampTKFV-2TKFV-22022-04-19
00844735006315GEM BIOVER Microvascular ClampTKSV-2TKSV-22022-04-19
00844735006322GEM BIOVER Microvascular ClampTKMV-2TKMV-22022-04-19
00844735006339GEM BIOVER Microvascular ClampTKLV-2TKLV-22022-04-19
00844735006346GEM BIOVER Microvascular ClampTKS-2TKS-22022-04-19
00844735006353GEM BIOVER Microvascular ClampTKM-2TKM-22022-04-19
00844735006360GEM BIOVER Microvascular ClampTKL-2TKL-22022-04-19
00844735002607GEM Microvascular Anastomotic COUPLERGEM27505111001000602015-10-08
00844735002621GEM Microvascular Anastomotic COUPLERGEM27515111001500602015-10-08
00844735002645GEM Microvascular Anastomotic COUPLERGEM27525111002000602015-10-08
00844735002683GEM Microvascular Anastomotic COUPLERGEM27545111003000602015-10-08
00844735002706GEM Microvascular Anastomotic COUPLERGEM27555121003500602015-10-08
00844735002720GEM Microvascular Anastomotic COUPLERGEM27565121004000602015-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844735006179GEM VESSEL EVERTERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2019-10-30
10844735006176GEM VESSEL EVERTERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2019-10-30
00844735002607GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002621GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002645GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002683GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002706GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002720GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002591GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
10844735002604GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002614GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
10844735002628GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002638GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
10844735002642GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002652GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
10844735002666GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002676GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
10844735002680GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002690GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
10844735002703GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735002713GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
10844735002727GEM Microvascular Anastomotic COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735005998GEM FLOW COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735006001GEM FLOW COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735006018GEM FLOW COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735006025GEM FLOW COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08
00844735006032GEM FLOW COUPLERSYNOVIS MICRO COMPANIES ALLIANCE, INCMVR2015-10-08