navaclick.comNavaClick Injection System
Lineage Biomedical, Inc.
LINEAGE BIOMEDICAL, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3030201489 | 3030201489 | LINEAGE BIOMEDICAL, INC | 1 | N | 2026-01-01 | 620 NW Dixie Hwy Stuart FL US 34994 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860009080515 | 025 NavaClick Syringe and Needle - 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. | (772)5399749 | info@navaclick.com |
| 00860009080522 | NavaClick Syringe and Needle - 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 0.02 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. | (772)5399749 | info@navaclick.com |
| 00860009080539 | 01 NavaClick Syringe and Needle - 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. | (772)5399749 | info@navaclick.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 324506 | 1557851286 | K231877 | NavaClick Injection System | FMF | 2023-11-30 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FMF | 1 | 2023-11-30 |
PMN#
GUDID#
025 NavaClick Syringe and Needle - 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.
2025-05-12
01 NavaClick Syringe and Needle - 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.
2025-05-12
NavaClick Syringe and Needle - 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 0.02 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.
2024-06-28
NavaClick Injection Kit - 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.
2024-01-30