| Primary Device ID | 10813465011163 |
| NIH Device Record Key | 5e88901c-0600-4bdd-b381-1afdcf9651bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IOL Manipulator - Sinskey |
| Version Model Number | 6804 |
| Catalog Number | 6804 |
| Company DUNS | 093377724 |
| Company Name | HURRICANE MEDICAL INC |
| Device Count | 5 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Length | 27 Millimeter |
| Outer Diameter | 0.2 Millimeter |
| Length | 27 Millimeter |
| Outer Diameter | 0.2 Millimeter |
| Length | 27 Millimeter |
| Outer Diameter | 0.2 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813465011166 [Primary] |
| GS1 | 10813465011163 [Unit of Use] |
| KYB | Lens, Guide, Intraocular |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10813465011163]
Moist Heat or Steam Sterilization;Radiation Sterilization;Ethylene Oxide
[10813465011163]
Moist Heat or Steam Sterilization;Radiation Sterilization;Ethylene Oxide
[10813465011163]
Moist Heat or Steam Sterilization;Radiation Sterilization;Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-18 |
| Device Publish Date | 2020-05-08 |
| 10813465011163 | Positioning of intraocular lens. Straight. Tip dimensions: diameter 0.20 mm, length 0.50 mm. |
| 10813465011149 | Positioning of intraocular lens. Angled 15 mm from tip. Tip dimensions: diameter 0.20 mm, length |