AccessGUDID - DEVICE: 01 NavaClick Syringe and Needle (00860009080539)

GUDID

Device Identifier (DI) Information

Brand Name: 01 NavaClick Syringe and Needle
Version or Model: LIN010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LIN010
Company Name: Lineage Biomedical, Inc.

Primary DI Number: 00860009080539
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111150837 *Terms of Use

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 0.01 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61a613be-254d-496b-b2e6-b42883a53830
Public Version Date: May 20, 2025
Public Version Number: 1
DI Record Publish Date: May 12, 2025