OCULUS SURGICAL INC

Address:562 NW Mercantile Pl Ste 104,Port St Lucie,FL,34986,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

General Surgery Tray (LRO) (2) Lens, Condensing, Diagnostic (HJL) (1)

Premarket Exempt

No Yes

Clear

SUPER VIEW Pack, HD, Disposable, for ZEISS RESIGHT® - 00856222004551 Catalog Number : 54018

Device Description : 1 Each 40220 SUPER VIEW® Lens Set, HD, Disposable, for ZEISS RESIGHT® & 1 Each 5 1 Each 40220 SUPER VIEW® Lens Set, HD, Disposable, for ZEISS RESIGHT® & 1 Each 55155 ZEISS RESIGHT Head Cover Drape

Device Class : 2

Duns Number: 015409582

Premarket Exempt : No

Product Code : LRO

Prescription Use : Yes

Device Count : 1

HD LenZ Pack Plus, for ZEISS RESIGHT® - 00856222004728 Catalog Number : 54019

Device Description : 1 Each 54416 HD LenZ for ZEISS RESIGHT®, 1 Each 40417 Hassan-Tornambe Contact Le 1 Each 54416 HD LenZ for ZEISS RESIGHT®, 1 Each 40417 Hassan-Tornambe Contact Lens, & 1 Each 51555 ZEISS RESIGHT® Microscope Head Cover Drape

Device Class : 2

Duns Number: 015409582

Premarket Exempt : No

Product Code : LRO

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Disposable Lens Set, Pivot - 00856222004742 Catalog Number : 40223

Device Description : 1 Each SUPER VIEW® Sterile Disposable Pivot Lens Set for use with the SUPER VIEW 1 Each SUPER VIEW® Sterile Disposable Pivot Lens Set for use with the SUPER VIEW® System or BIOM®

Device Class : 1

Duns Number: 015409582

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : Yes

Device Count : 1

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