Identity
- Trade Name
- 01 NavaClick Syringe and Needle FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- LIN010 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- LIN010 FDA UDI
- Primary DI / UDI-DI
- 00860009080539 FDA UDI
- FDA Product Code
- FMF FDA UDIFMI FDA UDI
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose syringe/needle
01 NavaClick Syringe and Needle by Lineage Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lineage Biomedical, Inc.
Sources (1)
- FDA UDI 61a613be-254d-496b-b2e6-b42883a53830 35 fields · synced May 30, 2026