INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Address:11 Cabot Blvd.,Mansfield,MA,02048,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, NATURAL (GAL) (6) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (4)

Premarket Exempt

No Yes

Clear

Integra® Jarit® - 00381780169348 Catalog Number :

Device Description : Disposable Hardy Bayonet Insulated Bipolar Forceps

Device Class :

Duns Number: 081277700

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 00381780169355 Catalog Number :

Device Description : Disposable Hardy Bayonet Non-Insulated Bipolar Forceps

Device Class :

Duns Number: 081277700

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Integra® Jarit® - 00381780176988 Catalog Number :

Device Description : Disposable Bipolar Cord

Device Class :

Duns Number: 081277700

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Miltex® Padgett® - 00381780177343 Catalog Number : PM-9450D

Device Description : Disposable Bipolar Cable

Device Class :

Duns Number: 081277700

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Miltex® - 00381780363791 Catalog Number :

Device Description : 18" SZ 5-0 CHRMIC GUT ABS C-3 CIR PREM REV CUT

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GAL

Prescription Use : Yes

Device Count : 1

Miltex® - 00381780363807 Catalog Number :

Device Description : 18" SZ 4-0 CHRMIC GUT ABS C-6 NEEDLE CIR REV CUT

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GAL

Prescription Use : Yes

Device Count : 1

Miltex® - 00381780363814 Catalog Number :

Device Description : 18" SZ 3-0 CHRMIC GUT ABS C-6 NEEDLE CIR REV CUT

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GAL

Prescription Use : Yes

Device Count : 1

Miltex® - 00381780363821 Catalog Number :

Device Description : 18" SZ 3-0 PLAIN GUT ABS C-3 CIR PREM REV CUT

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GAL

Prescription Use : Yes

Device Count : 1

Miltex® - 00381780363838 Catalog Number :

Device Description : 18" SZ 3-0 PLAIN GUT ABS C-6 NEEDLE CIR REV CUT

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GAL

Prescription Use : Yes

Device Count : 1

Miltex® - 00381780363845 Catalog Number :

Device Description : 18" SZ 4-0 PLAIN GUT ABS C-6 NEEDLE CIR REV CUT

Device Class : 2

Duns Number: 081277700

Premarket Exempt : No

Product Code : GAL

Prescription Use : Yes

Device Count : 1

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