| Primary Device ID | 00630238006835 |
| NIH Device Record Key | 95660023-765b-4eee-bdf6-d5366a2c4ed1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fundus Laser Lens NMR |
| Version Model Number | OGFA-2 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630238006835 [Primary] |
| GS1 | 00630238020268 [Direct Marking] |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
[00630238006835]
High-level Disinfectant
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-09 |