RELIEVA TRACT RT1640A

GUDID 20705031462646

RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM

ACCLARENT, INC.

Nasal/paranasal balloon catheter

• Primary Device ID: 20705031462646
• NIH Device Record Key: 9ce10360-a6e1-477f-af63-1ef5f0338321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIEVA TRACT
• Version Model Number: RT1640A
• Catalog Number: RT1640A
• 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	10705031462649 [Primary]
GS1	20705031462646 [Package]; Contains: 10705031462649; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183090

FDA Product Code

• QGK: Balloon, nasal airway

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: 2019-05-31

On-Brand Devices [RELIEVA TRACT]

• 20705031462653: RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK
• 20705031462639: RELIEVA TRACT BALLOON DILATION SYSTEM, 14X40MM - 1PK
• 20705031462615: RELIEVA TRACT BALLOON DILATION SYSTEM, 12X40MM - 1PK
• 20705031462592: RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM - 1PK
• 20705031462646: RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM
• 20705031462622: RELIEVA TRACT BALLOON DILATION SYSTEM, 14X40MM
• 20705031462608: RELIEVA TRACT BALLOON DILATION SYSTEM, 12X40MM
• 20705031462585: RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM