GEM Microvascular Anastomotic COUPLER System

FDA UDI

Class II (US FDA UDI)

by Synovis Micro Companies Alliance, Inc

Identity

Trade Name: GEM Microvascular Anastomotic COUPLER System FDA UDI
Generic Name: Vascular anastomosis coupling kit, reusable FDA UDI
Device Name: The GEM Microvascular Anastomotic COUPLER System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, and reusable Microvascular Anastomotic COUPLER Sterilization Tray. FDA UDI
Model / Reference: GEM 2741CC FDA UDI
Description: The GEM Microvascular Anastomotic COUPLER System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, and reusable Microvascular Anastomotic COUPLER Sterilization Tray. FDA UDI

Identifiers

Catalog Number: 519301006010 FDA UDI
Primary DI / UDI-DI: 00844735005226 FDA UDI
510(k) Number: K071783 FDA UDI
FDA Product Code: KCT FDA UDI
MDM FDA UDI
HTD FDA UDI
GMDN Term: Vascular anastomosis coupling kit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6850 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vascular anastomosis coupling kit, reusable

GEM Microvascular Anastomotic COUPLER System by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K071783 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Synovis Micro Companies Alliance, Inc

Sources (1)

FDA UDI 62e5fae7-e47d-4004-8735-1686ac4e165c 37 fields · synced Jun 1, 2026