RELIEVA ULTIRRA BC0616RU

GUDID 20705031200279

RELIEVA ULTIRRA SINUS BALLOON CATHETER 6x16

ACCLARENT, INC.

Nasal/paranasal balloon catheter

• Primary Device ID: 20705031200279
• NIH Device Record Key: c5b5199c-0574-4731-8a28-d3b609a0e7d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIEVA ULTIRRA
• Version Model Number: BC0616RU
• Catalog Number: BC0616RU
• 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: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

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
• 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
• 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
• 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	10705031200272 [Primary]
GS1	20705031200279 [Package]; Contains: 10705031200272; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111254

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: 2016-10-01

On-Brand Devices [RELIEVA ULTIRRA]

• 20705031200293: RELIEVA ULTIRRA SINUS BALLOON CATHETER 7x24
• 20705031200286: RELIEVA ULTIRRA SINUS BALLOON CATHETER 7x16
• 20705031200279: RELIEVA ULTIRRA SINUS BALLOON CATHETER 6x16
• 20705031200255: RELIEVA ULTIRRA SINUS BALLOON CATHETER 5x16