025 NavaClick Syringe and Needle

Basic Information

• Brand Name: 025 NavaClick Syringe and Needle
• Primary DI: 00860009080515
• Version / Model: LIN025
• Catalog Number: LIN025
• Company Name: Lineage Biomedical, Inc.
• Labeler DUNS: 111150837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-12
• Public Version: 1
• Public Version Date: 2025-05-20
• Public Version Status: New
• Public Device Record Key: b539db14-80cf-43f3-99a9-442d93796235

Device Description

The NavaClick Syringe is a manually operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1mL volume) and has audible and tactile feedback upon delivery of each 0.025 mL fluid, The syringe has been designed to enhance the efficiency and precision of neurotoxin injections. The syringe has been packaged with a LDS needle, size 0.24 x 9mm, for convenience. The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
FMF	Syringe, Piston	General Hospital	880.5860	2
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63095	General-purpose syringe/needle	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009080515	GS1

Customer Contacts

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