Primary Device ID | 10818255010623 |
NIH Device Record Key | 5d56853b-7828-4c0f-9d41-cbb9dfdb1fd2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | N/A |
Version Model Number | N/A |
Catalog Number | 5160 |
Company DUNS | 013486803 |
Company Name | MICROVISION, 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 | 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 |
Outer Diameter | 0.51 Millimeter |
Special Storage Condition, Specify | Between 0 and 0 *keep away from direct sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10818255010623 [Primary] |
GS1 | 30818255010627 [Package] Package: carton [5 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 | 2018-04-04 |
10818255011088 | Dual Bore Subretinal BSS Injection Needle, 23Ga. with 0.1mm/41Ga. tip |
30818255011051 | Disposable Viscous Fluid Injection Cannula, 23Ga. with 10mm thin-wall polyimide tip |
30818255010887 | Disposable Dual Bore PFC Cannula, 23Ga. |
10818255010661 | Charles Flute Cannula, 23Ga. |
10818255010647 | Retinal Cannula with Silicone Brush Tip, 23Ga. |
10818255010630 | Retinal Cannula with Silicone Top, 23Ga. |
10818255010623 | Retinal Cannula with Silicone Brush Tip, 25Ga. |
10818255010593 | Charles Flute Cannula, 25Ga. |
30818255010566 | Retinal Cannula with Silicone Tip, 25Ga. |
30818255011037 | Disposable One-Step Trocar System, 25Ga. (3 Trocar Knives with Pre-Loaded Self-Sealing Trocar Ca |
30818255011020 | Disposable Two-Step Trocar System, 23Ga. (3 Trocar Cannula Inserters with Pre-Loaded Self-Sealin |
30818255010979 | Disposable One-Step Trocar System, 23Ga. (3 Trocar Knives with Pre-Loaded Self-Sealing Trocar Ca |
10818255010791 | Fixation Plate and Marker for 23Ga. Vitrectomy |
10818255010715 | Reusable Two-Step Trocar System with Closure Plugs, 23Ga. |
10818255010548 | Disposable One-Step Trocar System, 25Ga. (4 insert handles with preloaded trocars & 1 infusion l |
10818255010319 | Scleral Plug Forceps |