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

CLAMP, VASCULAR (DXC) (9) SYSTEM, SKIN CLOSURE (MKY) (1)

Premarket Exempt

No Yes

Clear

DERMACLOSE - 00844735006223 Catalog Number : 580120000011

Device Description : Continuous External Tissue Expander

Device Class : 1

Duns Number: 031284586

Premarket Exempt : No

Product Code : MKY

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006230 Catalog Number : TKFV1

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006247 Catalog Number : TKSV1

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006254 Catalog Number : TKMV1

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006261 Catalog Number : TKLV1

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006278 Catalog Number : TKS1

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006285 Catalog Number : TKM1

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006292 Catalog Number : TKL1

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006308 Catalog Number : TKFV2

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

GEM BIOVER Microvascular Clamp - 00844735006315 Catalog Number : TKSV2

Device Description : Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

Device Class : 2

Duns Number: 031284586

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

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