SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT® 40424

GUDID 10856222004657

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

INSIGHT INSTRUMENTS, INC.

Diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens

• Primary Device ID: 10856222004657
• NIH Device Record Key: 424e57d8-a836-4bdc-b797-ddf0eab022f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®
• Version Model Number: TS-ZR-SV
• Catalog Number: 40424
• Company DUNS: 828348391
• Company Name: INSIGHT INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856222004650 [Primary]
GS1	10856222004657 [Package]; Contains: 00856222004650; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• HJL: Lens, Condensing, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

Devices Manufactured by INSIGHT INSTRUMENTS, INC.

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• 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®: 2018-07-06 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