Gem Microtray Max

FDA UDI

Class I (US FDA UDI)

by Synovis Micro Companies Alliance, Inc

Identity

Trade Name: GEM MICROTRAY MAX FDA UDI
Generic Name: Vascular anastomosis coupling kit, reusable FDA UDI
Device Name: The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, two MircoClip Appliers and a double tier MicroTray Sterilization Tray. FDA UDI
Model / Reference: GEM2551-2-CS FDA UDI
Description: The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, two MircoClip Appliers and a double tier MicroTray Sterilization Tray. FDA UDI

Identifiers

Catalog Number: 519321006011 FDA UDI
Primary DI / UDI-DI: 00844735005875 FDA UDI
510(k) Number: K071783 FDA UDI
FDA Product Code: GDO FDA UDI
HTD FDA UDI
KCT FDA UDI
MDM FDA UDI
GMDN Term: Vascular anastomosis coupling kit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
880.6850 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vascular anastomosis coupling kit, reusable

Gem Microtray Max by Synovis Micro Companies Alliance, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular anastomosis coupling kit, reusable.

GEM Microvascular Anastomotic COUPLER System — SYNOVIS MICRO COMPANIES ALLIANCE, INC · Class II
GEM MICROTRAY MAX — SYNOVIS MICRO COMPANIES ALLIANCE, INC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Synovis Micro Companies Alliance, Inc

Sources (1)

FDA UDI 6285a36b-fb8b-4f6f-86ec-1d1c059c35cc 37 fields · synced May 30, 2026