FDA Registration
Active
🇺🇸 United States
OCUJECT, LLC
Reg #: 3012478173
·
FEI: 3012478173
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- OCUJECT, LLC
- Registration Number
- 3012478173
- FEI Number
- 3012478173
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 13240 Evening Creek Dr S Ste 304
- City
- San Diego
- State
- CA
- ZIP
- 92128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170768
Owner / Operator
- Firm Name
- OcuJect, LLC
- Operator Number
- 10051392
- Address
- 1441 Avocado Avenue, Suite 204
- City
- Newport Beach
- State
- CA
- Postal Code
- 92660
- Country
- US
- Correspondent
- Laurence Harvey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2017-09-01 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2022-11-03 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-10-15 |
| Ophthalmic Needle | QYM | Class 2 | General Hospital | No | 2024-10-31 |
| Low Dead Space Needle, Single Lumen, Hypodermic | QNS | Class 2 | General Hospital | No | 2024-10-31 |
| Low Dead Space Piston Syringe | QNQ | Class 2 | General Hospital | No | 2024-01-03 |
| Ophthalmic Syringe | QLY | Class 2 | General Hospital | No | 2024-01-03 |
Proprietary Names
Mini Needle
SteriCap Mini Needle
VitreJect® Needle; OcuSafe® Needle
SteriLoad
VitreJect Safety Needle
MiniLoad Syringe
SteriCap® LDS Safety Needle
OcuSafe® LDS Needle
VitreJect® LDS Safety Needle
VitreJect Syringe
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility