SYNOVIS MICRO COMPANIES ALLIANCE, INC

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- Catalog Number : 515101250010

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

- Catalog Number : 515101300010

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 : MVR, DPW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 515101350010

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

- Catalog Number : 515101400010

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

- Catalog Number : 521440250010

Device Description : Reusable bipolar forceps designed to function as active electrodes or as accesso Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 521440251010

Device Description : Reusable bipolar forceps designed to function as active electrodes or as accesso Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 521440500010

Device Description : Reusable bipolar forceps designed to function as active electrodes or as accesso Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 521440501010

Device Description : Reusable bipolar forceps designed to function as active electrodes or as accesso Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 521440750010

Device Description : Reusable bipolar forceps designed to function as active electrodes or as accesso Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 521440751010

Device Description : Reusable bipolar forceps designed to function as active electrodes or as accesso Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1