FDA.reportPublic FDA data

GEM COUPLER Forceps

Primary DI
00844735002850
Brand
GEM COUPLER Forceps
Company
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Model
GEM4183C
Catalog number
519306001010
Device description
Reusable instrument used to grasp the blood vessel and evert onto the GEM COUPLER rings.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844735006698Direct MarkingGS10
00844735002850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844735006698008447350066988447350066980844735006698
00844735002850008447350028508447350028500844735002850

GMDN Terms#

Term, Definition table
TermDefinition
Vascular anastomosis coupling forcepsA non-sterile, hand-held manual surgical instrument designed for use during vascular (including microvascular) anastomosis surgical procedures to place the ends of the blood vessel over the pins of a vascular anastomosis coupler. It is made of metal. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
031284586
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
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
00724995323578V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323585V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323608V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323615V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
10886982357298VOLTSynthes GmbHHTD2026-09-25
10886982357304VOLTSynthes GmbHHTD2026-09-25
10886982357311VOLTSynthes GmbHHTD2026-09-25
10886982357328VOLTSynthes GmbHHTD2026-09-25
10886982357854VOLTSynthes GmbHHTD2026-09-25
10886982357861VOLTSynthes GmbHHTD2026-09-25
10886982357878VOLTSynthes GmbHHTD2026-09-25
10886982357885VOLTSynthes GmbHHTD2026-09-25
00810238290063PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00810238290087PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713916PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713930PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713947PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00190776431082MillenniumAvalign Technologies, Inc.HTD2026-09-21
00190776430962MillenniumAvalign Technologies, Inc.HTD2026-09-18
00192896123755Debakey-Diethrich Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-09-18
00190776424015MillenniumAvalign Technologies, Inc.HTD2026-08-27
00192896123632Adson Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-08-27
00190776419738MillenniumAvalign Technologies, Inc.HTD2026-08-25
00850088713596PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
00850088713619PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
04054462901821evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901852evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901869evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901876evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901883evonosevonos GmbH & Co. KGHTD2026-08-21