SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT® 40226
GUDID 10856222004060
1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distributed by THEA Surgical (Insight's REF 40226)
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 | 10856222004060 |
| NIH Device Record Key | 6e78b8d5-b206-443d-b36c-f3a7c245095b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT® |
| Version Model Number | TS-ZR-LS |
| Catalog Number | 40226 |
| 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 |
| CustomerService@InsightInstruments.com | |
| Phone | (772) 219-9393 |
| CustomerService@InsightInstruments.com | |
| Phone | (772) 219-9393 |
| CustomerService@InsightInstruments.com | |
| Phone | (772) 219-9393 |
| CustomerService@InsightInstruments.com | |
| Phone | (772) 219-9393 |
| CustomerService@InsightInstruments.com | |
| Phone | (772) 219-9393 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856222004063 [Primary] |
| GS1 | 10856222004060 [Package] Contains: 00856222004063 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® | 2018-07-06 1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens |
| 10856222004060 - SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT® | 2018-07-061 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distributed by THEA Surgical (Insight's REF 40226) |
| 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 |
Trademark Results [SUPER VIEW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPER VIEW 86774161 4986920 Live/Registered |
All-Time Manufacturing Co. Inc. 2015-09-30 |
 SUPER VIEW 85756491 4450018 Live/Registered |
Insight Instruments, Inc. 2012-10-17 |
 SUPER VIEW 80983684 0983684 Dead/Cancelled |
U.S. Home Security Systems 0000-00-00 |
 SUPER VIEW 76354184 2654200 Dead/Cancelled |
MEGA BRANDS INTERNATIONAL, LUXEMBOURG, ZUG BRANCH 2001-12-31 |
 SUPER VIEW 74139910 not registered Dead/Abandoned |
CIVELLI, KEN 1991-02-19 |
 SUPER VIEW 73409267 1269697 Dead/Cancelled |
Sorcim Corporation 1983-01-13 |
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