| Primary Device ID | 00630238121002 |
| NIH Device Record Key | e4fc146d-879c-477f-b422-4a29a7e9266b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 1.0mm Fundus Laser Lens |
| Version Model Number | OFA1.0 |
| Company DUNS | 046212387 |
| Company Name | OCULAR 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 | 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 | 00630238056670 [Direct Marking] |
| GS1 | 00630238121002 [Primary] |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
[00630238121002]
High-level Disinfectant
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-18 |
| Device Publish Date | 2019-06-10 |