ETHICON, LLC

Address:Highway 183 Km. 8.3,San Lorenzo,PR,00754,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) Suture, surgical, absorbable, polydioxanone (NEW) (2) Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed (OTO) (1) SUTURE, ABSORBABLE, SYNTHETIC (GAN) (1)

Premarket Exempt

No Yes

Clear

PDS - 10705031469402 Catalog Number : PDPB347H

Device Description : Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture

Device Class : 2

Duns Number: 079402290

Premarket Exempt : No

Product Code : NEW

Prescription Use : Yes

Device Count : 1

PDS - 10705031469419 Catalog Number : Z513ZG

Device Description : Violet Monofilament (Polydioxanone), Absorbable Surgical Suture

Device Class : 2

Duns Number: 079402290

Premarket Exempt : No

Product Code : NEW

Prescription Use : Yes

Device Count : 1

MONOCRYL - 10705031469440 Catalog Number : Y4213H

Device Description : Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture

Device Class : 2

Duns Number: 079402290

Premarket Exempt : No

Product Code : GAN

Prescription Use : Yes

Device Count : 1

Coated VICRYL - 17891338030407 Catalog Number : J324H

Device Description : Coated Vicryl (Polyglactin 910) Suture, Violet Braided, Sterile, Synthetic Abso Coated Vicryl (Polyglactin 910) Suture, Violet Braided, Sterile, Synthetic Absorbable Suture

Device Class : 2

Duns Number: 079402290

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

Coated VICRYL - 17891338030414 Catalog Number : J350H

Device Description : Violet Braided (Polyglactin 910), Synthetic Absorbable Suture

Device Class : 2

Duns Number: 079402290

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

Coated VICRYL - 17891338030612 Catalog Number : J318H

Device Description : Violet Braided (Polyglactin 910), Synthetic Absorbable Suture

Device Class : 2

Duns Number: 079402290

Premarket Exempt : No

Product Code : GAM

Prescription Use : Yes

Device Count : 1

GYNECARE GYNEMESH - 20705031037738 Catalog Number : GPSL

Device Description : Nonabsorable PROLENE, soft mesh

Device Class : 2

Duns Number: 829465157

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

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