| Primary Device ID | 10856222004671 |
| NIH Device Record Key | 11f845a9-9f0d-4fe8-bd48-08f3866b10c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RETRECTOR® |
| Version Model Number | 71005 |
| Catalog Number | 71005 |
| 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 | true |
| 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 | 23 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856222004674 [Primary] |
| GS1 | 10856222004671 [Package] Contains: 00856222004674 Package: Case [5 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| 10856222004671 | 1 RETRECTOR® Probe Kit containing 1 Each Syringe 10ml & 1 Each Disposable 23 Ga Vitrectomy Prob |
| 00856222004667 | 1 Each Disposable 23 Ga vitrectomy probe with retractable tip for use with the INTRECTOR® Kit d |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RETRECTOR 85582239 4234063 Dead/Cancelled |
Insight Instruments, Inc. 2012-03-28 |