FDA.reportPublic FDA data

GEM VESSEL EVERTER

Primary DI
10844735006176
Brand
GEM VESSEL EVERTER
Company
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Model
GEM2742
Catalog number
519600001061
Device description
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.
Published
2019-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190499000Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.2019-09-06MVR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10844735006176PackageGS16In Commercial Distribution
00844735006179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084473500617610844735006176
00844735006179008447350061798447350061790844735006179

GMDN Terms#

Term, Definition table
TermDefinition
Vascular anastomosis coupling kit, single-useA collection of devices intended to be used to implant a vascular anastomosis coupler [not included] to join vascular (including microvascular) structures by the coupling of two ring-shaped components. It consists of two or more items typically amongst: a coupling approximator for holding the rings of the coupler during approximation, a dedicated forceps/everter for placing the ends of the blood vessel over the pins of the coupler, and a vessel diameter guide (sizer). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)510-3318MEDINFO_MEDPRODUCTS@BAXTER.COM

Regulatory Flags#

DUNS number
031284586
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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
00844735002669GEM Microvascular Anastomotic COUPLERGEM27535111002500602015-10-08
00844735002683GEM Microvascular Anastomotic COUPLERGEM27545111003000602015-10-08
00844735002706GEM Microvascular Anastomotic COUPLERGEM27555121003500602015-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844735006179GEM 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
00844735002669GEM 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