IMPLANT DIRECT SYBRON MANUFACTURING LLC

Address:3050 East Hillcrest Drive,Thousand Oaks,CA,91362,US

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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

Suture, Absorbable, Synthetic, Polyglycolic Acid (GAM) (3)

Premarket Exempt

No Yes

Clear

Vilet™ - 10841307130635 Catalog Number : V393U

Device Description : Vilet PGLA 3/0 FS-2 [3/8C RevCt 19mm] 18” Undyed

Device Class : 2

Duns Number: 868856969

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

Vilet II Quick™ - 10841307130642 Catalog Number : VGQ386

Device Description : Vilet II Quick PGA 4/0 C-3 [3/8C RevCt 13mm] 18" Undyed

Device Class : 2

Duns Number: 868856969

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

Vilet II Quick™ - 10841307130659 Catalog Number : VGQ392

Device Description : Vilet II Quick PGA 4/0 FS-2 [3/8C RevCt 19mm] 18" Undyed

Device Class : 2

Duns Number: 868856969

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

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