OcuSafe Ophthalmic Needle

Basic Information

• Brand Name: OcuSafe Ophthalmic Needle
• Primary DI: 00855265008564
• Version / Model: PN0403-03
• Company Name: Ocuject, LLC
• Labeler DUNS: 017559643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-16
• Public Version: 1
• Public Version Date: 2024-12-24
• Public Version Status: New
• Public Device Record Key: c102b866-7e87-4ba3-b8c2-e9697e9d22b8

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QNS	Low Dead Space Needle, Single Lumen, Hypodermic	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00855265008571	GS1	Inner Pack	100	In Commercial Distribution
Primary	00855265008564	GS1
Package	00855265008731	GS1	Shipping Box	5000	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K242956	000