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| 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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