| Primary Device ID | 00850037925957 |
| NIH Device Record Key | 81b96d81-3b21-42d1-8c33-a3b719b0e8c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VitreJect Ophthalmic Syringe |
| Version Model Number | PN0209-12 |
| Company DUNS | 017559643 |
| Company Name | Ocuject, LLC |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com | |
| Phone | (949) 721-6716 |
| support@ocuject.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850037925940 [Primary] |
| GS1 | 00850037925957 [Package] Contains: 00850037925940 Package: Inner Pack [250 Units] In Commercial Distribution |
| GS1 | 00850037925964 [Package] Package: Shipping Box [1000 Units] In Commercial Distribution |
| QLY | Ophthalmic Syringe |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-10 |
| Device Publish Date | 2025-02-28 |
| 00850037925834 | The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The |
| 00850037925957 | The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The |