| Primary Device ID | 10856222004626 |
| NIH Device Record Key | 4690d482-dfdd-4b7f-ac41-a5a7065ccd61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insight Instruments, Inc. Infusion Cannula |
| Version Model Number | 60013 |
| Catalog Number | 60013 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (772) 219-9393 |
| CustomerService@InsightInstruments.com |
| Needle Gauge | 26 Gauge |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856222004629 [Primary] |
| GS1 | 10856222004626 [Package] Contains: 00856222004629 Package: Case [10 Units] In Commercial Distribution |
| HMX | Cannula, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-09-23 |
| 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 | 2019-10-07Self-retaining 26 Ga cannula with sharp tip for infusion of the posterior vitreous cavity during vitreo-retinal procedures |
| 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 |