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GEM Microvascular Anastomotic COUPLER

FDA UDI

Class II (US FDA UDI)

by Synovis Micro Companies Alliance, Inc

Identity

Trade Name
GEM Microvascular Anastomotic COUPLER FDA UDI
Generic Name
Vascular anastomosis coupler, basic FDA UDI
Device Name
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 FDA UDI
Model / Reference
GEM2750 FDA UDI
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 FDA UDI

Identifiers

Catalog Number
511100100060 FDA UDI
Primary DI / UDI-DI
00844735002607 FDA UDI
FDA Product Code
MVR FDA UDI
GMDN Term
Vascular anastomosis coupler, basic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Vascular anastomosis coupler, basic

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

Similar devices

Also classified as Vascular anastomosis coupler, basic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synovis Micro Companies Alliance, Inc

Sources (1)

  • FDA UDI a1f097e5-d48b-468b-91dc-728b52e0595a 35 fields · synced Jun 8, 2026