SYNOVIS MICRO COMPANIES ALLIANCE, INC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device,anastomotic,microvascular (MVR) (10)

Premarket Exempt

No Yes

Clear

GEM Microvascular Anastomotic COUPLER - 00844735002591 Catalog Number : 511100100010

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002607 Catalog Number : 511100100060

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002614 Catalog Number : 511100150010

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002621 Catalog Number : 511100150060

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002638 Catalog Number : 511100200010

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002645 Catalog Number : 511100200060

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002652 Catalog Number : 511100250010

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002669 Catalog Number : 511100250060

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002676 Catalog Number : 511100300010

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

GEM Microvascular Anastomotic COUPLER - 00844735002683 Catalog Number : 511100300060

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

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : MVR

Prescription Use : Yes

Device Count : 1

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