| Primary Device ID | 00850040387377 |
| NIH Device Record Key | d1c10f36-23ed-4745-9e52-0164f5415ae2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VitreJect-DL Ophthalmic Needle |
| Version Model Number | PN0625-03 |
| 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 |
| 00850037925957 - VitreJect Ophthalmic Syringe | 2025-03-10 The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated f |
| 00850040387377 - VitreJect-DL Ophthalmic Needle | 2025-03-10The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The VitreJect® LDS Safety Needle has a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The VitreJect® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needles are suitable for intravitreal use. |
| 00850040387377 - VitreJect-DL Ophthalmic Needle | 2025-03-10 The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lum |
| 00855265008038 - VitreJect Ophthalmic Needle | 2025-03-10 The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lum |
| 00850037925834 - VitreJect Ophthalmic Syringe | 2025-03-10 The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated f |
| 10855265008868 - VitreJect Ophthalmic Needle | 2025-03-10 The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lum |
| 00855265008892 - VitreJect Ophthalmic Needle | 2025-03-10 The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lum |
| 00855265008922 - VitreJect Ophthalmic Needle | 2025-03-10 The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lum |
| 00855265008403 - VitreJect Syringe | 2023-09-18 The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hol |