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Gem Flow Coupler

FDA UDI

Class II (US FDA UDI)

by Synovis Micro Companies Alliance, Inc

Identity

Trade Name
GEM FLOW COUPLER FDA UDI
Generic Name
Vascular anastomosis coupler, Doppler FDA UDI
Device Name
The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FlowCOUPLER rings, and an external lead. The FlowCOUPLER rings are made of high density polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and probe which allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable. FDA UDI
Model / Reference
GEM2753 FC FDA UDI
Description
The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FlowCOUPLER rings, and an external lead. The FlowCOUPLER rings are made of high density polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and probe which allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable. FDA UDI

Identifiers

Catalog Number
515101250010 FDA UDI
Primary DI / UDI-DI
00844735006001 FDA UDI
FDA Product Code
DPW FDA UDI
MVR FDA UDI
GMDN Term
Vascular anastomosis coupler, Doppler FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2100 FDA UDI
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, Doppler

Gem Flow 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, Doppler.

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 1bac7d84-cf41-478f-81e6-3e65f93b99ed 35 fields · synced Jun 1, 2026