SYNOVIS MICRO COMPANIES ALLIANCE, INC

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- Catalog Number : 512100350010

Device Description : The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene 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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 512100350060

Device Description : The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene 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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 512100400010

Device Description : The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene 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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 512100400060

Device Description : The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene 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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 519302003010

Device Description : A reusable, single tier sterilization tray, consisting of an anodized aluminum b A reusable, single tier sterilization tray, consisting of an anodized aluminum base and cover with instrument holder bars. The tray is designed to hold the Anastomotic Instrument, Vessel Measuring Gauge, and up to two Coupler Forceps for steam sterilization and storage between uses.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

- Catalog Number : 519304002010

Device Description : A reusable instrument used to estimate the outside diameter of a blood vessel (1mm - 4mm).

Device Class :

Duns Number: 031284586

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

- Catalog Number : 519306001010

Device Description : Reusable instrument used to grasp the blood vessel and evert onto the GEM COUPLER rings.

Device Class :

Duns Number: 031284586

Premarket Exempt : Yes

Product Code : HTD

Prescription Use : No

Device Count : 1

- Catalog Number : 519400002011

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 and instrument holder bar.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 519400003011

Device Description : A highly perforated, reusable, double tier, sterilization tray consisting of an A highly perforated, reusable, double tier, sterilization tray consisting of an anodized aluminum base, insert, and cover with handles and latches and full finger mats on both upper and lower tiers.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 519400004011

Device Description : A highly perforated, reusable, double tier, sterilization tray consisting of an A highly perforated, reusable, double tier, sterilization tray consisting of an anodized aluminum base, insert, and cover with handles and latches including upper tier full finger mat and lower tier finger mat and instrument holders

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1