ETHICON INC.

Address:3348 PULLIAM ST.,SAN ANGELO,TX,76905,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

HYSTEROSCOPE (AND ACCESSORIES) (HIH) (9) DEVICE, THERMAL ABLATION, ENDOMETRIAL (MNB) (1)

Premarket Exempt

No Yes

Clear

GYNECARE VERSAPOINT - 10705031000773 Catalog Number : 00466

Device Description : Electrode - Ball Tip. 5Fr (1.6mm nom.) x 360mm.

Device Class :

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

GYNECARE VERSAPOINT - 10705031000780 Catalog Number : 00467

Device Description : Electrode - Twizzle Tip. 5Fr (1.6mm nom.) x 360mm.

Device Class :

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

GYNECARE VERSAPOINT - 10705031000797 Catalog Number : 00468

Device Description : Electrode - Spring Tip. 5Fr (1.6mm nom.) x 360mm.

Device Class :

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

GYNECARE VERSAPOINT - 10705031000803 Catalog Number : 00480

Device Description : Hysteroscopic System Connector Cable

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

GYNECARE VERSAPOINT - 10705031000810 Catalog Number : 00481

Device Description : Hysteroscopic System Footswitch

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

GYNECARE THERMACHOICE - 10705031000865 Catalog Number : 00825

Device Description : Uterine Balloon Therapy System

Device Class : 3

Duns Number: 002144145

Premarket Exempt : No

Product Code : MNB

Prescription Use : Yes

Device Count : 1

GYNECARE VERSAPOINT - 10705031000919 Catalog Number : 01735

Device Description : Resectoscopic System, Bridge - Hysteroscopic (Obturator - Visual)

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

GYNECARE VERSAPOINT - 10705031000926 Catalog Number : 01931

Device Description : Resectoscopic System, Working Element, Passive

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

GYNECARE VERSAPOINT - 10705031000933 Catalog Number : 01934

Device Description : Resectoscopic System, Obturator, Standard

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

GYNECARE VERSAPOINT - 10705031000940 Catalog Number : 01936

Device Description : Resectoscopic System, Hysteroscope 4.0mm 30°, Wide Angle

Device Class : 2

Duns Number: 002144145

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

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