ACCLARENT NAVWIRE GW35150NZ

GUDID 20705031237084

ACCLARENT NAVWIRE SINUS NAVIGATION GUIDEWIRE

ACCLARENT, INC.

Paranasal sinus guidewire

• Primary Device ID: 20705031237084
• NIH Device Record Key: 08a494cb-ad33-4f91-b551-3b5a49114adb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCLARENT NAVWIRE
• Version Model Number: GW35150NZ
• Catalog Number: GW35150NZ
• 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

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	10705031237087 [Primary]
GS1	20705031237084 [Package]; Contains: 10705031237087; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161697

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: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-08-01

On-Brand Devices [ACCLARENT NAVWIRE]

• 20705031242903: ACCLARENT NAVWIRE SINUS NAVIGATION GUIDEWIRE
• 20705031237084: ACCLARENT NAVWIRE SINUS NAVIGATION GUIDEWIRE