NavaClick Injection Kit

Primary DI
10860009080505
Brand
NavaClick Injection Kit
Company
Lineage Biomedical, Inc.
Model
NBK20
Catalog number
NBK20
Device description
The 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.
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009080505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086000908050510860009080505

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(772)539-9749info@navaclick.com

Regulatory Flags#

DUNS number
111150837
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009080515025 NavaClick Syringe and NeedleLIN025LIN0252025-05-12
0086000908053901 NavaClick Syringe and NeedleLIN010LIN0102025-05-12
00860009080522NavaClick Syringe and NeedleLIN02LIN022024-06-28

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Primary DI, Brand, Company table
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