TruDi NAV Cable TDNC001Z

GUDID 20705031245867

TruDi NAV Cable - 1PK

ACCLARENT, INC.

Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 20705031245867
• NIH Device Record Key: 7063249d-302c-4eeb-9765-235689a9f6fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruDi NAV Cable
• Version Model Number: TDNC001Z
• Catalog Number: TDNC001Z
• 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(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705031245867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180948

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: 2018-10-31

On-Brand Devices [TruDi NAV Cable]

• 20705031245867: TruDi NAV Cable - 1PK
• 20705031245850: TruDi NAV Cable - 5PK