APPLIED DENTAL, 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

Suture, Surgical, Absorbable, Polydioxanone (NEW) (8) Suture, Absorbable, Synthetic, Polyglycolic Acid (GAM) (2)

Premarket Exempt

No Yes

Clear

UNIFY PDO Surgical Sutures - 00814639020816 Catalog Number :

Device Description : UNIFY PDO Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : NEW

Prescription Use : No

Device Count : 1

UNIFY PDO Surgical Sutures - 00814639020823 Catalog Number :

Device Description : UNIFY PDO Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : NEW

Prescription Use : No

Device Count : 1

UNIFY PDO Surgical Sutures - 00814639020830 Catalog Number :

Device Description : UNIFY PDO Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : NEW

Prescription Use : No

Device Count : 1

UNIFY PDO Surgical Sutures - 00814639020847 Catalog Number :

Device Description : UNIFY PDO Surgical Sutures, absorbable, 6-0, 13mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : NEW

Prescription Use : No

Device Count : 1

UNIFY PDO Surgical Sutures - 00814639020854 Catalog Number :

Device Description : UNIFY PDO Surgical Sutures, Absorbable, XL 0, 30mm 3/8 Circle Rev Cut, 30"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : NEW

Prescription Use : No

Device Count : 1

UNIFY PDO Surgical Sutures - 00814639020861 Catalog Number :

Device Description : UNIFY PDO Surgical Sutures, Absorbable, XL 0, 36mm 1/2 Circle Taper Pt, 30"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : NEW

Prescription Use : No

Device Count : 1

UNIFY PDO Surgical Sutures - 00814639020878 Catalog Number :

Device Description : UNIFY PDO Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : NEW

Prescription Use : No

Device Count : 1

UNIFY PDO Surgical Sutures - 00814639020885 Catalog Number :

Device Description : UNIFY PDO Surgical Sutures, Absorbable, XXL 1, 40mm 3/8 Circle Rev Cut, 30"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : NEW

Prescription Use : No

Device Count : 1

UNIFY PGA Surgical Sutures - 00814639020892 Catalog Number :

Device Description : UNIFY PGA Surgical Sutures Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAM

Prescription Use : No

Device Count : 1

UNIFY PGA Surgical Sutures - 00814639020908 Catalog Number :

Device Description : UNIFY PGA Surgical Sutures, Absorbable, LG 2-0, 26mm 1/2 Circle Taper Pt, 30"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAM

Prescription Use : No

Device Count : 1

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