INSIGHT INSTRUMENTS, INC.

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Device Description : 1 Each Sterile Disposable 27 Ga Vitreous Biopsy Probe for use with the INTRECTOR® Kit

Device Class : 2

Duns Number: 828348391

Premarket Exempt : No

Product Code : HKP

Prescription Use : Yes

Device Count : 1

Device Description : Dispenser Box of 5 Each Sterile Disposable 27 Ga Vitreous Biopsy Probes for use Dispenser Box of 5 Each Sterile Disposable 27 Ga Vitreous Biopsy Probes for use with the INTRECTOR® Kit & 5 Each 10cc Luer Lock Syringes

Device Class : 2

Duns Number: 828348391

Premarket Exempt : No

Product Code : HKP

Prescription Use : Yes

Device Count : 1

Device Description : 1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens

Device Class : 2

Duns Number: 828348391

Premarket Exempt : No

Product Code : HJK

Prescription Use : Yes

Device Count : 1

Device Description : 1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact L 1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distributed by THEA Surgical (Insight's REF 40226)

Device Class : 2

Duns Number: 828348391

Premarket Exempt : No

Product Code : HJK

Prescription Use : Yes

Device Count : 1

- Catalog Number : 71102

Device Description : INTRECTOR® Power Unit for use with the INTRECTOR® Portable Vitrectomy System REF: 71200

Device Class : 2

Duns Number: 828348391

Premarket Exempt : No

Product Code : HKP

Prescription Use : Yes

Device Count : 1

- Catalog Number : 71101

Device Description : INTRECTOR® Handpiece for use with the INTRECTOR® Portable Vitrectomy System REF: 71200

Device Class : 2

Duns Number: 828348391

Premarket Exempt : No

Product Code : HKP

Prescription Use : Yes

Device Count : 1

Device Description : Self-retaining 26 Ga cannula with sharp tip for infusion of the posterior vitreo Self-retaining 26 Ga cannula with sharp tip for infusion of the posterior vitreous cavity during vitreo-retinal procedures

Device Class : 1

Duns Number: 828348391

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

- Catalog Number : 71004

Device Description : 1 INTRECTOR® Probe Kit containing 1 Each Syringe 1ml, 1 Each Syringe 3ml, & 1 Ea 1 INTRECTOR® Probe Kit containing 1 Each Syringe 1ml, 1 Each Syringe 3ml, & 1 Each Disposable 23 Ga Vitrectomy Probe

Device Class :

Duns Number: 828348391

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : 1 Disposable 23 Ga Vitrectomy Probe for use with the INTRECTOR® KIT

Device Class : 2

Duns Number: 828348391

Premarket Exempt : No

Product Code : HKP

Prescription Use : Yes

Device Count : 1

Device Description : 1 Each Sterile Disposable Wide Field Lens for use with the ZEISS RESIGHT®. Distr 1 Each Sterile Disposable Wide Field Lens for use with the ZEISS RESIGHT®. Distributed by THEA Surgical (Insight's REF 40424)

Device Class : 1

Duns Number: 828348391

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : Yes

Device Count : 1