SUPER VIEW® Disposable Lens Set for RESIGHT® 40219

GUDID 10856222004046

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

INSIGHT INSTRUMENTS, INC.

Vitrectomy contact lens, single-use

• Primary Device ID: 10856222004046
• NIH Device Record Key: 23811077-7247-44c5-b347-3e31ea684f56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPER VIEW® Disposable Lens Set for RESIGHT®
• Version Model Number: 40219
• Catalog Number: 40219
• Company DUNS: 828348391
• Company Name: INSIGHT INSTRUMENTS, 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) 219-9393
• Email: CustomerService@InsightInstruments.com
• Phone: (772) 219-9393
• Email: CustomerService@InsightInstruments.com
• Phone: (772) 219-9393
• Email: CustomerService@InsightInstruments.com
• Phone: (772) 219-9393
• Email: CustomerService@InsightInstruments.com
• Phone: (772) 219-9393
• Email: CustomerService@InsightInstruments.com
• Phone: (772) 219-9393
• Email: CustomerService@InsightInstruments.com

Device Dimensions

• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 18 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856222004049 [Primary]
GS1	10856222004046 [Package]; Contains: 00856222004049; Package: Case [20 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by INSIGHT INSTRUMENTS, INC.

• 10856222004831 - SUPER VIEW® Pack for ZEISS RESIGHT®: 2020-02-06 1 Each 40226 ZEISS RESIGHT® Disposable Lens Set & 1 Each ZEISS RESIGHT® Headcover Drape. Distributed by THEA Surgical (Insight
• 10856222004848 - SUPER VIEW® Pack for ZEISS RESIGHT®: 2020-02-06 1 Each 40226 ZEISS RESIGHT® Disposable Lens Set & 1 Each ZEISS RESIGHT® Full Body Drape. Distributed by THEA Surgical (Insight
• 10856222004626 - Insight Instruments, Inc. Infusion Cannula: 2019-10-07 Self-retaining 26 Ga cannula with sharp tip for infusion of the posterior vitreous cavity during vitreo-retinal procedures
• 10856222004046 - SUPER VIEW® Disposable Lens Set for RESIGHT®: 2018-07-061 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens
• 10856222004046 - SUPER VIEW® Disposable Lens Set for RESIGHT®: 2018-07-06 1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens
• 10856222004060 - SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT®: 2018-07-06 1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distributed by THEA Surgical (Insight's RE
• 00852475007004 - Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga: 2018-03-29 1 Each Sterile Disposable 27 Ga Vitreous Biopsy Probe for use with the INTRECTOR® Kit
• 00852475007011 - Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga: 2018-03-29 Dispenser Box of 5 Each Sterile Disposable 27 Ga Vitreous Biopsy Probes for use with the INTRECTOR® Kit & 5 Each 10cc Luer Lock
• 00856222004186 - INTRECTOR®: 2018-03-29 INTRECTOR® Power Unit for use with the INTRECTOR® Portable Vitrectomy System REF: 71200