SYNOVIS MICRO COMPANIES ALLIANCE, INC

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- Catalog Number : 519400001011

Device Description : A highly perforated, reusable, single tier, sterilization tray consisting of an A highly perforated, reusable, single tier, sterilization tray consisting of an anodized aluminum base and cover with handles and latches and a full finger mat.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 515510010010

Device Description : GEM FLOW COUPLER Monitor Power supply & cord

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DPW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 515400000010

Device Description : The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for the The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DPW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 515410000040

Device Description : An external lead that joins the FLOW COUPLER probe to the FLOW COUPLER Monitor

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DPW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 519301006010

Device Description : The GEM Microvascular Anastomotic COUPLER System consists of a reusable Anastomo 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.

Device Class : 1

Duns Number: 031284586

Premarket Exempt : No

Product Code : KCT, MDM, HTD

Prescription Use : Yes

Device Count : 1

- Catalog Number : 519303002010

Device Description : A reusable Instrument designed to hold the GEM COUPLER device and approximate th A reusable Instrument designed to hold the GEM COUPLER device and approximate the GEM COUPLER rings during vessel anastomosis

Device Class :

Duns Number: 031284586

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

- Catalog Number : 519400005011

Device Description : A highly perforated, reusable, single tier, sterilization tray consisting of an A highly perforated, reusable, single tier, sterilization tray consisting of an anodized aluminum base and cover with handles and latches and a full finger mat.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 519311006011

Device Description : The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two 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 single tier MicroTray Sterilization Tray.

Device Class : 1

Duns Number: 031284586

Premarket Exempt : No

Product Code : HTD, GDO, MDM, KCT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 519321006011

Device Description : The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two 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.

Device Class : 1

Duns Number: 031284586

Premarket Exempt : No

Product Code : GDO, HTD, KCT, MDM

Prescription Use : Yes

Device Count : 1

- Catalog Number : 515101200010

Device Description : The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monito 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.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DPW, MVR

Prescription Use : Yes

Device Count : 1