NavaClick Injection Kit NBK20

GUDID 10860009080505

General-purpose syringe/needle

Primary Device ID	10860009080505
NIH Device Record Key	aad1f0d0-df09-4b9d-b28f-dc43cf9afbcf
Commercial Distribution Status	In Commercial Distribution
Brand Name	NavaClick Injection Kit
Version Model Number	NBK20
Catalog Number	NBK20
Company DUNS	111150837
Company Name	Lineage Biomedical, Inc.
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	true
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	10860009080505 [Primary]

FMF	Syringe, Piston

Steralize Prior To Use	false
Device Is Sterile	true

00860009080522 - NavaClick Syringe and Needle	2024-07-08 The NavaClick Syringe is a manually operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer
10860009080505 - NavaClick Injection Kit	2024-02-07The NavaClick Injector 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 (1 mL volume), and has audible and tactile feedback upon delivery of each 0.02 mL fluid. The syringe has been designed to enhance the efficiency and precision of neurotoxin injections. The syringe has been packaged with other components for convenience. The NavaClick Injection System is a kit containing the NavaClick Injectors (syringes), needles, and a vial adapter for delivery of neurotoxin per the labeled indication. The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
10860009080505 - NavaClick Injection Kit	2024-02-07 The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard lue