TruDi NAV Suction

Basic Information

• Brand Name: TruDi NAV Suction
• Primary DI: 10705031245877
• Version / Model: TDNS000Z
• Catalog Number: TDNS000Z
• Company Name: ACCLARENT, INC.
• Labeler DUNS: 361092450
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-20
• Public Version: 3
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 8c1ab2c3-4015-4367-8e31-eb5f67731eb6

Device Description

TruDi NAV Suction, 0° - 1PK

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Hydrogen Peroxide"]

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
62783	Electromagnetic/optical surgical navigation device tracking system	A mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	80705031245876	GS1
Primary	10705031245877	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180948	000

Storage Conditions

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