RELIEVA ULTIRRA NAV BC0516RUN

GUDID 20705031238708

RELIEVA ULTIRRA NAV SINUS BALLOON CATHETER, 5x16MM

ACCLARENT, INC.

Nasal/paranasal balloon catheter

• Primary Device ID: 20705031238708
• NIH Device Record Key: 7afbbf6e-b89f-40ae-9a5e-402a988e081f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIEVA ULTIRRA NAV
• Version Model Number: BC0516RUN
• Catalog Number: BC0516RUN
• Company DUNS: 361092450
• Company Name: ACCLARENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	10705031238701 [Primary]
GS1	20705031238708 [Package]; Contains: 10705031238701; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161698

FDA Product Code

• LRC: INSTRUMENT, ENT MANUAL SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-08-01

Devices Manufactured by ACCLARENT, INC.

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• 20705031469263 - TruDi Shaver Blade: 2022-09-19 Trudi Shaver Blade 4.0mm - 40° Curved - 1pk