Integra Lifesciences Corporation

Address:105 and 109 MORGAN LANE,PLAINSBORO,NJ,08536,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

Material, Dressing, Surgical, Polylactic Acid (LPG) (4) Syringe, Piston (FMF) (4) Regulator, Pressure, Gas Cylinder (CAN) (1) Sealant, Dural (NQR) (1)

Premarket Exempt

No Yes

Clear

DuraSeal Exact Spinal Sealant System - 10381780000044 Catalog Number : 206520

Device Description : DuraSeal Exact Spinal Sealant System 5mL 5 pack

Device Class : 3

Duns Number: 083171244

Premarket Exempt : No

Product Code : NQR

Prescription Use : Yes

Device Count : 1

MicroMyst - 10381780000112 Catalog Number : 205000DS

Device Description : MicroMyst Applicator (14cm) 5 pack - for use with Flow Regulator

Device Class : 2

Duns Number: 083171244

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Extended Tip Applicator - 10381780000143 Catalog Number : 205108

Device Description : Extended Tip Applicator 8cm 5 pack

Device Class : 2

Duns Number: 083171244

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Extended Tip Applicator - 10381780000150 Catalog Number : 205115

Device Description : Extended Tip Applicator 15cm 5 pack

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Extended Tip Applicator - 10381780000167 Catalog Number : 201108

Device Description : Extended Tip Applicator 8cm single pack

Device Class : 2

Duns Number: 083171244

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Integra® - 10381780000174 Catalog Number : FR6065

Device Description : Flow Regulator intended to be used with MicroMyst® Applicator. It's intended to Flow Regulator intended to be used with MicroMyst® Applicator. It's intended to provide pressurized gas (air or nitrogen) to Integra gas-assisted applicators.

Device Class : 1

Duns Number: 083171244

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

CollaPlug® - 10381780000259 Catalog Number : 0102

Device Description : CollaPlug® Absorbable Collagen Wound Dressing, 3/8in x 3/4in

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : LPG

Prescription Use : Yes

Device Count : 10

CollaCote® - 10381780000266 Catalog Number : 0101

Device Description : CollaCote ®Absorbable Collagen Wound Dressing, 3/4in x 1 1/2in

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : LPG

Prescription Use : Yes

Device Count : 10

CollaTape® - 10381780000273 Catalog Number : 0100

Device Description : CollaTape ® Absorbable Collagen Wound Dressing, 1in x 3in

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : LPG

Prescription Use : Yes

Device Count : 10

HeliTape® - 10381780000280 Catalog Number : 62-200

Device Description : HeliTape ® ABSORBABLE COLLAGEN Wound Dressing, 1in x 3in

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : LPG

Prescription Use : Yes

Device Count : 10

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