| Primary Device ID | 00630238120326 |
| NIH Device Record Key | cedd83e7-9548-4584-a03d-444f74e4d6d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Upright 1.3x Surgical Gonio Lens w/Handle |
| Version Model Number | OUSG-1.3X-H |
| Company DUNS | 046212387 |
| Company Name | OCULAR 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630238120326 [Primary] |
| GS1 | 00630238120333 [Direct Marking] |
| HKS | Prism, Gonioscopic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
[00630238120326]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-18 |
| Device Publish Date | 2019-06-10 |