TruDi NAVWIRE

Basic Information

• Brand Name: TruDi NAVWIRE
• Primary DI: 20705031245911
• Version / Model: TDNW001Z
• Catalog Number: TDNW001Z
• Company Name: ACCLARENT, INC.
• Labeler DUNS: 361092450
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-20
• Public Version: 2
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: a749a1ab-d81a-4d01-891a-c04f7e252ab0

Device Description

TruDi NAVWIRE Sinus Navigation Guidewire - 1PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PGW	Ear, Nose, and Throat Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48145	Paranasal sinus guidewire	A sterile device intended to be used to provide a means to access the paranasal sinuses for diagnostic and therapeutic procedures (e.g., sinuplasty). It is made of stiff but bendable material, typically with a preshaped radiopaque distal tip and a lubricious coating to enable precise steering to navigate the anatomy of the sinuses. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20705031245911	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190532	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place