SUPER VIEW® Lens, Disposable Contact, Hassan-Tornambe 40417

GUDID 10856222004039

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

OCULUS SURGICAL INC

Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use

• Primary Device ID: 10856222004039
• NIH Device Record Key: 94f8a5fa-9e91-4eb6-80fe-2b671c9ec3d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPER VIEW® Lens, Disposable Contact, Hassan-Tornambe
• Version Model Number: 40417
• Catalog Number: 40417
• Company DUNS: 015409582
• Company Name: OCULUS SURGICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (772) 236-2622
• Email: sales@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com
• Phone: (772) 236-2622
• Email: info@oculussurgical.com

Device Dimensions

• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856222004032 [Primary]
GS1	10856222004039 [Package]; Contains: 00856222004032; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051630

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-11
• Device Publish Date: 2016-09-23

Devices Manufactured by OCULUS SURGICAL INC

• 00852475007134 - BIOM Optic Set, HD Professional, for f=175mm: 2022-02-23 1 BIOM Optic Set, HD Professional, for f=175mm
• 10852475007148 - BIOM Optic Set, HD Professional, for f=200mm: 2022-02-23 1 BIOM Optic Set, HD Professional, for f=200mm
• 00852475007158 - BIOM Optic Set, HD Flex: 2022-02-23 1 BIOM Optic Set, HD Flex
• 00852475007172 - HD Disposable, LenZ: 2022-02-23 1 HD Disposable LenZ
• 00852475007219 - Versa Optic Set, for f=175mm: 2022-02-02 1 Versa Optic Set, for f=175mm
• 00852475007257 - Versa Optic Set, for f=200mm: 2022-02-02 1 Versa Optic Set, for f=200mm
• 10852475007209 - Contact Lens, HD Professional, Cohen-Benner, "CBC": 2021-03-08 1 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"
• 00852475007271 - VERSA HD Disposable LenZ: 2020-12-14 1 VERSA HD Disposable LenZ