VitreJect Ophthalmic Needle

GUDID 00855265008038

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.

Ocuject, LLC

Hypodermic needle, single-use

• Primary Device ID: 00855265008038
• NIH Device Record Key: 0e81efc6-4578-4d80-bc9f-7bd4498ce8fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitreJect Ophthalmic Needle
• Version Model Number: PN0404-03
• 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

Customer Support Contacts

• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com
• Phone: (949) 721-6716
• Email: support@ocuject.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855265008038 [Primary]
GS1	00855265008076 [Package]; Package: Inner Pack [100 Units]; In Commercial Distribution
GS1	00855265008113 [Package]; Contains: 00855265008076; Package: Shipping Box [5000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242956

FDA Product Code

• QYM: Ophthalmic Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-10
• Device Publish Date: 2025-02-28

On-Brand Devices [VitreJect Ophthalmic Needle]

• 00855265008922: The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspira
• 00855265008892: The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspira
• 10855265008868: The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspira
• 00855265008038: The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspira