TruDi NAVWIRE TDNW001Z

GUDID 20705031245911

TruDi NAVWIRE Sinus Navigation Guidewire - 1PK

ACCLARENT, INC.

Paranasal sinus guidewire

• Primary Device ID: 20705031245911
• NIH Device Record Key: a749a1ab-d81a-4d01-891a-c04f7e252ab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruDi NAVWIRE
• Version Model Number: TDNW001Z
• Catalog Number: TDNW001Z
• Company DUNS: 361092450
• Company Name: ACCLARENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)775-2789
• Email: xxxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705031245911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190532

FDA Product Code

• PGW: Ear, Nose, and Throat Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-22
• Device Publish Date: 2019-10-20

On-Brand Devices [TruDi NAVWIRE]

• 20705031245911: TruDi NAVWIRE Sinus Navigation Guidewire - 1PK
• 20705031245904: TruDi NAVWIRE Sinus Navigation Guidewire - 5PK