INSIGHT INSTRUMENTS, INC.

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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

Instrument, Vitreous Aspiration And Cutting, Battery-Powered (HKP) (1) Lens, Condensing, Diagnostic (HJL) (1)

Premarket Exempt

No Yes

Clear

RETRECTOR® - 00856222004667 Catalog Number :

Device Description : 1 Each Disposable 23 Ga vitrectomy probe with retractable tip for use with the I 1 Each Disposable 23 Ga vitrectomy probe with retractable tip for use with the INTRECTOR® Kit during vitreo-retinal surgery

Device Class : 2

Duns Number: 828348391

Premarket Exempt : No

Product Code : HKP

Prescription Use : Yes

Device Count : 1

RETRECTOR® - 00856222004674 Catalog Number : 71005

Device Description : 1 RETRECTOR® Probe Kit containing 1 Each Syringe 10ml & 1 Each Disposable 23 Ga 1 RETRECTOR® Probe Kit containing 1 Each Syringe 10ml & 1 Each Disposable 23 Ga Vitrectomy Probe with retractable tip

Device Class :

Duns Number: 828348391

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

INTRECTOR® - 00856222004759 Catalog Number : 71200

Device Description : INTRECTOR® Portable Vitrectomy System including REF: 71102 Power Unit & REF: 711 INTRECTOR® Portable Vitrectomy System including REF: 71102 Power Unit & REF: 71101 Handpiece

Device Class :

Duns Number: 828348391

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT® - 00856222004827 Catalog Number : 40414

Device Description : 1 Each Sterile Disposable RESIGHT® Wide Field Lens

Device Class : 1

Duns Number: 828348391

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Pack for ZEISS RESIGHT® - 00856222004834 Catalog Number : 40224

Device Description : 1 Each 40226 ZEISS RESIGHT® Disposable Lens Set & 1 Each ZEISS RESIGHT® Headcove 1 Each 40226 ZEISS RESIGHT® Disposable Lens Set & 1 Each ZEISS RESIGHT® Headcover Drape. Distributed by THEA Surgical (Insight's REF 40224)

Device Class :

Duns Number: 828348391

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Pack for ZEISS RESIGHT® - 00856222004841 Catalog Number : 40225

Device Description : 1 Each 40226 ZEISS RESIGHT® Disposable Lens Set & 1 Each ZEISS RESIGHT® Full Bod 1 Each 40226 ZEISS RESIGHT® Disposable Lens Set & 1 Each ZEISS RESIGHT® Full Body Drape. Distributed by THEA Surgical (Insight's REF 40225)

Device Class :

Duns Number: 828348391

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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