INTRAVU, INC.

Address:610 Price Ave,Redwood City,CA,94063,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

Arthroscope (HRX) (10) Laparoscope, General & Plastic Surgery (GCJ) (10)

Premarket Exempt

Clear

AccessVu 90 - 00850023905000 Catalog Number : IV-ASY-1609

Device Description : Disposable accessory kit to be used with IntraVu Scope 90.Kit contains 90mm cann Disposable accessory kit to be used with IntraVu Scope 90.Kit contains 90mm cannula, 90mm trocar, cannula cap and stopcock.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : HRX, GCJ

Prescription Use : Yes

Device Count : 1

AccessVu 60 - 00850023905017 Catalog Number : IV-ASY-1606

Device Description : Disposable accessory kit to be used with IntraVu Scope 60.Kit contains 60mm cann Disposable accessory kit to be used with IntraVu Scope 60.Kit contains 60mm cannula, 60mm trocar, cannula cap and stopcock.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : HRX, GCJ

Prescription Use : Yes

Device Count : 1

AccessVu 120 - 00850023905024 Catalog Number : IV-ASY-1612

Device Description : Disposable accessory kit to be used with IntraVu Scope 120.Kit contains 120mm ca Disposable accessory kit to be used with IntraVu Scope 120.Kit contains 120mm cannula, 120mm trocar, cannula cap and stopcock.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : HRX, GCJ

Prescription Use : Yes

Device Count : 1

MIDAScope™ - 120 and Introducer Kit - 00865351000303 Catalog Number : IV-ASY-0600

Device Description : Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock.MIDASco Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock.MIDAScope™ is a miniaturized, sterile, single-use disposable scope for use with the MIDASystem™ reusable video processing unit.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

MIDASystem™ - 00865351000310 Catalog Number : IV-ASY-0450

Device Description : MIDASystem™ is a reusable visualization system for use with the MIDAScope™

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

MIDAScope™ - 90 and Introducer Kit - 00865351000327 Catalog Number : IV-ASY-0700

Device Description : Kit containing 90mm Scope and 90mm Cannula, 90mm Trocar, and Stopcock.MIDAScope™ Kit containing 90mm Scope and 90mm Cannula, 90mm Trocar, and Stopcock.MIDAScope™ is a miniaturized, sterile, single-use disposable scope for use with the MIDASystem™ reusable video processing unit.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

MIDAScope™ - 60 and Introducer Kit - 00865351000334 Catalog Number : IV-ASY-0800

Device Description : Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock.MIDAScope™ Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock.MIDAScope™ is a miniaturized, sterile, single-use, disposable scope for use with the MIDASystem™ reusable video processing unit.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

IntraVu Scope 120 - 00865351000341 Catalog Number : IV-ASY-1120

Device Description : Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock.IntraVu Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock.IntraVu Scope is a miniaturized, sterile, single-use disposable scope for use with the IntraVu Tablet reusable video processing unit.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : HRX, GCJ

Prescription Use : Yes

Device Count : 1

IntraVu Scope 90 - 00865351000358 Catalog Number : IV-ASY-1090

Device Description : Kit containing 90mm Scope and 90mm Cannula, 90mm Trocar, and Stopcock.IntraVu Sc Kit containing 90mm Scope and 90mm Cannula, 90mm Trocar, and Stopcock.IntraVu Scope is a miniaturized, sterile, single-use disposable scope for use with the IntraVu Tablet reusable video processing unit.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : HRX, GCJ

Prescription Use : Yes

Device Count : 1

IntraVu Scope 60 - 00865351000365 Catalog Number : IV-ASY-1060

Device Description : Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock.IntraVu Sc Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock.IntraVu Scope is a miniaturized, sterile, single-use, disposable scope for use with the IntraVu Tablet reusable video processing unit.

Device Class : 2

Duns Number: 116708692

Premarket Exempt : No

Product Code : HRX, GCJ

Prescription Use : Yes

Device Count : 1

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