01 NavaClick Syringe and Needle LIN010

GUDID 00860009080539

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 0.01 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.

Lineage Biomedical, Inc.

General-purpose syringe/needle
Primary Device ID00860009080539
NIH Device Record Key61a613be-254d-496b-b2e6-b42883a53830
Commercial Distribution StatusIn Commercial Distribution
Brand Name01 NavaClick Syringe and Needle
Version Model NumberLIN010
Catalog NumberLIN010
Company DUNS111150837
Company NameLineage Biomedical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com
Phone(772)5399749
Emailinfo@navaclick.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009080539 [Primary]

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

Devices Manufactured by Lineage Biomedical, Inc.

00860009080515 - 025 NavaClick Syringe and Needle2025-05-20 The NavaClick Syringe is a manually operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer
00860009080539 - 01 NavaClick Syringe and Needle2025-05-20The 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 0.01 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.
00860009080539 - 01 NavaClick Syringe and Needle2025-05-20 The NavaClick Syringe is a manually operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer
00860009080522 - NavaClick Syringe and Needle2024-07-08 The NavaClick Syringe is a manually operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer
10860009080505 - NavaClick Injection Kit2024-02-07 The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard lue

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