ocuject.comLDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
Ocuject, LLC
OCUJECT, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012478173 | 3012478173 | OCUJECT, LLC | 1 | Y | 2026-01-01 | 13240 Evening Creek Dr S Ste 304 San Diego CA US 92128 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850037925940 | VitreJect Ophthalmic Syringe - The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use. | (949) 721-6716 | support@ocuject.com |
| 00850037925957 | VitreJect Ophthalmic Syringe - The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use. | (949) 721-6716 | support@ocuject.com |
| 00850040387360 | VitreJect-DL Ophthalmic Needle - The 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. | (949) 721-6716 | support@ocuject.com |
| 00855265008540 | VitreJect-DS Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume. | (949) 721-6716 | support@ocuject.com |
| 00855265008854 | VitreJect Ophthalmic Syringe - The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use. | (949) 721-6716 | support@ocuject.com |
| 00855265008861 | VitreJect Ophthalmic Needle - The 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. | (949) 721-6716 | support@ocuject.com |
| 00855265008885 | VitreJect Ophthalmic Needle - The 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. | (949) 721-6716 | support@ocuject.com |
| 00855265008915 | VitreJect Ophthalmic Needle - The 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. | (949) 721-6716 | support@ocuject.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 192299 | 1633576385 | K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | QNS | 2024-10-25 |
| 192299 | 1760071024 | K233343 | SteriCap Safety Needle; VitreJect Safety Needle | FMI | 2023-11-27 |
| 192299 | 1894517041 | K230959 | VitreJect® Needle; OcuSafe® Needle | FMI | 2023-09-14 |
| 192299 | 1496092815 | K230372 | VitreJect Syringe | QLY | 2023-09-08 |
| 192299 | 1583496922 | K212544 | MiniLoad Syringe | FMF | 2021-10-13 |
| 192299 | 1562620437 | K183016 | SteriCap Mini Needle | FMI | 2019-05-07 |
| 192299 | 1350448814 | K170768 | Mini Needle | FMI | 2017-07-10 |
| 192299 | 1395739506 |
Product Codes Associated With Registrations#
PMN#
SteriCap Safety Needle; VitreJect Safety Needle
Ocuject, LLC
VitreJect® Needle; OcuSafe® Needle
Ocuject, LLC
VitreJect Syringe
Ocuject, LLC
MiniLoad Syringe
OcuJect, LLC
SteriCap Mini Needle And Standard Needles
OcuJect, LLC
MiniLoad Syringe
OcuJect, LLC
Mini Needle
OcuJect, LLC
GUDID#
VitreJect-DS Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-09-08
VitreJect Ophthalmic Syringe - The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.
2025-02-28
VitreJect-DL Ophthalmic Needle - The 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.
2025-02-28
VitreJect Ophthalmic Syringe - The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.
2025-02-28
VitreJect Ophthalmic Needle - The 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.
2025-02-28
VitreJect Ophthalmic Needle - The 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.
2025-02-28
VitreJect Ophthalmic Needle - The 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.
2025-02-28
VitreJect Ophthalmic Syringe - The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.
2025-02-28
VitreJect-DL Ophthalmic Needle - The 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.
2025-02-28
VitreJect Ophthalmic Needle - The 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.
2025-02-28
VitreJect Ophthalmic Syringe - The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.
2025-02-28
VitreJect Ophthalmic Needle - The 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.
2025-02-28
VitreJect Ophthalmic Needle - The 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.
2025-02-28
VitreJect Ophthalmic Needle - The 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.
2025-02-28
OcuSafe-XL Ophthalmic Needle - The OcuSafe® LDS 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 OcuSafe® LDS Needles have a removable cap that is removed prior to the needle’s use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The OcuSafe® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The OcuSafe® LDS Needles are suitable for intravitreal use.
2024-12-16
VitreJect-DL Ophthalmic Needle - The 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.
2024-12-16
VitreJect-DL Ophthalmic Needle - The 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.
2024-12-16
VitreJect-DLX Ophthalmic Needle - The 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.
2024-12-16
OcuSafe Ophthalmic Needle - The OcuSafe® LDS 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 OcuSafe® LDS Needles have a removable cap that is removed prior to the needle’s use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The OcuSafe® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The OcuSafe® LDS Needles are suitable for intravitreal use.
2024-12-16
VitreJect Ophthalmic Needle - The 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.
2024-12-16
VitreJect Ophthalmic Needle - The 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.
2024-12-16
OcuSafe Ophthalmic Needle - The OcuSafe® LDS 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 OcuSafe® LDS Needles have a removable cap that is removed prior to the needle’s use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The OcuSafe® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The OcuSafe® LDS Needles are suitable for intravitreal use.
2024-12-16
OcuSafe Ophthalmic Needle - The OcuSafe® LDS 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 OcuSafe® LDS Needles have a removable cap that is removed prior to the needle’s use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The OcuSafe® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The OcuSafe® LDS Needles are suitable for intravitreal use.
2024-12-16
OcuSafe Ophthalmic Needle - The OcuSafe® LDS 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 OcuSafe® LDS Needles have a removable cap that is removed prior to the needle’s use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The OcuSafe® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The OcuSafe® LDS Needles are suitable for intravitreal use.
2024-12-16
VitreJect Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31
VitreJect Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31
VitreJect Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31
VitreJect Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-09-08
VitreJect Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-09-08
VitreJect Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-09-08
VitreJect Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-09-08
MiniLoad Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31
MiniLoad Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31
MiniLoad Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31
MiniLoad Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31
MiniLoad Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31
MiniLoad Syringe - The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
2023-08-31