| Primary Device ID | 10810080612485 |
| NIH Device Record Key | 3f5be414-8daf-4378-8a2c-ddd240b28f25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiDropper® |
| Version Model Number | UA15-415-50-BOT-10BRW |
| Company DUNS | 117970217 |
| Company Name | MPS Pharma & Medical, 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810080612488 [Primary] |
| GS1 | 10810080612485 [Package] Contains: 00810080612488 Package: Case [500 Units] In Commercial Distribution |
| KYX | Dispenser, Liquid Medication |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-25 |
| Device Publish Date | 2025-08-15 |
| 10810080612461 | 15-415 Series 7ML OptiDropper®, Bottle Natural Cylinder Round Tray |
| 10810080612485 | 15-415 Series OptiDropper® 10mL Dropper Bottle, White Boston Round |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OPTIDROPPER 98615651 not registered Live/Pending |
MPS PHARMA & MEDICAL, INC. 2024-06-24 |