| Primary Device ID | 10810080612492 |
| NIH Device Record Key | 9fdf4771-cebd-4e17-9a50-0c8f8a1844e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiDropper®, SafeFill™ |
| Version Model Number | UA15-415-50-TRAY-10 |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810080612495 [Primary] |
| GS1 | 10810080612492 [Package] Contains: 00810080612495 Package: Case [1000 Units] In Commercial Distribution |
| KYX | Dispenser, Liquid Medication |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
[10810080612492]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-27 |
| Device Publish Date | 2025-08-19 |
| 10810080612492 - OptiDropper®, SafeFill™ | 2025-08-2715-415 Series 10mL OptiDropper® Bottle, Natural Boston Round SafeFill™ Tray |
| 10810080612492 - OptiDropper®, SafeFill™ | 2025-08-27 15-415 Series 10mL OptiDropper® Bottle, Natural Boston Round SafeFill™ Tray |
| 10810080612485 - OptiDropper® | 2025-08-25 15-415 Series OptiDropper® 10mL Dropper Bottle, White Boston Round |
| 10810080612461 - OptiDropper® | 2025-07-28 15-415 Series 7ML OptiDropper®, Bottle Natural Cylinder Round Tray |
| 10810080612379 - OptiDropper™ | 2025-05-21 OptiDropper™ 15ML Sterile Dropper Bottle |
| 10810080612324 - OptiDropper™ | 2025-05-20 OptiDropper™ 3ML Sterile Dropper Bottle |
| 10810080612331 - OptiDropper™ | 2025-05-20 OptiDropper™ 3ML Sterile Dropper Bottle |
| 10810080612348 - OptiDropper™ | 2025-05-20 OptiDropper™ 7ML Sterile Dropper Bottle |
| 10810080612355 - OptiDropper™ | 2025-05-20 OptiDropper™ 7ML Sterile Dropper Bottle |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OPTIDROPPER 98615651 not registered Live/Pending |
MPS PHARMA & MEDICAL, INC. 2024-06-24 |