OCULUS SURGICAL INC

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

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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

Lens, Condensing, Diagnostic (HJL) (4) Lens, Contact, Polymethylmethacrylate, Diagnostic (HJK) (3) General Surgery Tray (LRO) (2) Prism, Gonioscopic (HKS) (1)

Premarket Exempt

No Yes

Clear

Versa Optic Set, for f=200mm - 00852475007240 Catalog Number : 54212

Device Description : 1 Versa Optic Set, for f=200mm

Device Class : 1

Duns Number: 015409582

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : Yes

Device Count : 1

VERSA HD Disposable LenZ - 00852475007264 Catalog Number :

Device Description : 1 VERSA HD Disposable LenZ

Device Class : 1

Duns Number: 015409582

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : Yes

Device Count : 1

Gonio Ready 200 for f=200mm - 00852475007332 Catalog Number : 53671

Device Description : 1 Each 53671 Gonio Ready 200 for f=200mm

Device Class : 1

Duns Number: 015409582

Premarket Exempt : Yes

Product Code : HKS

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Disposable Lens Set - 00856222004001 Catalog Number : 40411

Device Description : SUPER VIEW® Sterile Lens Pack for use with the SUPER VIEW® System and the BIOM®

Device Class :

Duns Number: 015409582

Premarket Exempt : No

Product Code : HJK

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Pack - 00856222004018 Catalog Number : 40213

Device Description : 1 Each 40411 Sterile Disposable SUPER VIEW® Lens Set & 1 Each 40101 Sterile Head 1 Each 40411 Sterile Disposable SUPER VIEW® Lens Set & 1 Each 40101 Sterile Headcover Drape

Device Class :

Duns Number: 015409582

Premarket Exempt : No

Product Code : LRO

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Pack - 00856222004025 Catalog Number : 40211

Device Description : 1 Each 40411 Sterile Disposable SUPER VIEW® Lens Set & 1 Each 40100 Sterile Micr 1 Each 40411 Sterile Disposable SUPER VIEW® Lens Set & 1 Each 40100 Sterile Microscope Drape

Device Class : 2

Duns Number: 015409582

Premarket Exempt : No

Product Code : LRO

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Lens, Disposable Contact, Hassan-Tornambe - 00856222004032 Catalog Number : 40417

Device Description : SUPER VIEW® Hassan-Tornambe Disposable Contact Lens for use during vitreo-retinal surgery

Device Class : 2

Duns Number: 015409582

Premarket Exempt : No

Product Code : HJK

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Disposable Lens Set, Essential - 00856222004056 Catalog Number : 40403

Device Description : SUPER VIEW® Sterile Essential Lens Pack for use with the SUPER VIEW® System and the BIOM®

Device Class : 1

Duns Number: 015409582

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Disposable Lens Set, Pivot Plus - 00856222004179 Catalog Number : 40227

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

Device Class : 2

Duns Number: 015409582

Premarket Exempt : No

Product Code : HJK

Prescription Use : Yes

Device Count : 1

SUPER VIEW® Disposable HD Lens Set for RESIGHT® - 00856222004544 Catalog Number : 40220

Device Description : SUPER VIEW® Disposable HD Lens Set for RESIGHT®

Device Class : 1

Duns Number: 015409582

Premarket Exempt : No

Product Code : HJL

Prescription Use : No

Device Count : 1

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