Southmedic Incorporated

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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

SYSTEM, SKIN CLOSURE (MKY) (8) TOPICAL APPROXIMATION SYSTEM (MZR) (2)

Premarket Exempt

No Yes

Clear

Dynamic Tissue Systems™ - 00620974001706 Catalog Number : DWS12

Device Description : SutureSafe Set

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 10

Dynamic Tissue Systems™ - 00620974001713 Catalog Number : DWS14

Device Description : SutureSafe Set

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 10

Dynamic Tissue Systems™ - 00620974001720 Catalog Number : DWC24

Device Description : DynaClose Set

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 4

Dynamic Tissue Systems™ - 00620974001737 Catalog Number : DWC38

Device Description : DynaClose Set

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 4

Dynamic Tissue Systems™ - 00620974001744 Catalog Number : DSX24

Device Description : DynaStretch Set

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 4

Dynamic Tissue Systems™ - 00620974001751 Catalog Number : DSX38

Device Description : DynaStretch Set

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 4

Dynamic Tissue Systems™ - 00620974001768 Catalog Number : DCX10

Device Description : DynaCleft Unilateral

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 7

Dynamic Tissue Systems™ - 00620974001775 Catalog Number : DCX20

Device Description : DynaCleft Bilateral

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 7

Dynamic Tissue Systems™ - 00620974001782 Catalog Number : DCNE-01

Device Description : DynaCleft Nasal Elevation System

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MZR

Prescription Use : Yes

Device Count : 7

Dynamic Tissue Systems™ - 00620974001799 Catalog Number : DCNE-02

Device Description : DynaCleft Nasal Elevation System

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : MZR

Prescription Use : Yes

Device Count : 28

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