Integra Lifesciences Corporation

Address:4900 CHARLEMAR DR.,,CINCINNATI,OH,45227,US

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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

Agent, Absorbable Hemostatic, Collagen Based (LMF) (4) Endoscope, Neurological (GWG) (3) Retractor, Self-Retaining, For Neurosurgery (GZT) (3) Sealant, Dural (NQR) (3)

Premarket Exempt

No Yes

Clear

Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE - 00381780000191 Catalog Number : 1690-ZZ

Device Description : ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 1/2IN X 1IN, 7MM THICK

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE - 00381780000207 Catalog Number : 3410-ZX

Device Description : ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 3IN X 4IN, 5MM THICK

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

Helitene® - 00381780000214 Catalog Number : 1692-ZK

Device Description : ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 1GRAM

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

Helitene® - 00381780000221 Catalog Number : 1692-ZL

Device Description : ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 0.5GRAM

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

Aurora Surgiscope System - 00850002332247 Catalog Number : ASX15/80

Device Description : The AURORA Surgiscope System consists of two components: sterile, single use, ne The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB). The AURORA Surgiscope includes the following parts: Sheath, Camera, LEDs (Light Emitting Diodes), Sheath Cable, and Obturator.

Device Class : 2

Duns Number: 083171244

Premarket Exempt : No

Product Code : GZT, GWG

Prescription Use : Yes

Device Count : 1

Aurora Surgiscope System - 00850002332254 Catalog Number : ASX15/60

Device Description : The AURORA Surgiscope System consists of two components: sterile, single use, n The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB). The AURORA Surgiscope includes the following parts: Sheath, Camera, LEDs (Light Emitting Diodes), Sheath Cable, and Obturator.

Device Class : 2

Duns Number: 083171244

Premarket Exempt : No

Product Code : GZT, GWG

Prescription Use : Yes

Device Count : 1

Aurora Surgiscope System - 00850002332261 Catalog Number : ICB/ASX15

Device Description : The Image Control Box (ICB) provides power to the AURORA Surgiscope, transfers t The Image Control Box (ICB) provides power to the AURORA Surgiscope, transfers the video to a Display Monitor, and allows the user to digitally adjust the image quality and orientation.

Device Class : 2

Duns Number: 083171244

Premarket Exempt : No

Product Code : GWG, GZT

Prescription Use : Yes

Device Count : 1

DuraSeal Dural Sealant System - 10381780000013 Catalog Number : 202010DS

Device Description : DuraSeal Dural Sealant System 5mL single pack

Device Class : 3

Duns Number: 083171244

Premarket Exempt : No

Product Code : NQR

Prescription Use : Yes

Device Count : 1

DuraSeal Dural Sealant System - 10381780000020 Catalog Number : 202050

Device Description : DuraSeal Dural Sealant System 5mL 5 pack

Device Class :

Duns Number: 083171244

Premarket Exempt : No

Product Code : NQR

Prescription Use : Yes

Device Count : 1

DuraSeal Exact Spinal Sealant System - 10381780000037 Catalog Number : 206320

Device Description : DuraSeal Exact Spinal Sealant System 3mL 5 pack

Device Class : 3

Duns Number: 083171244

Premarket Exempt : No

Product Code : NQR

Prescription Use : Yes

Device Count : 1

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