ACCLARENT PIVOT PVT0616L

GUDID 20705031465579

ACCLARENT PIVOT Illumination Balloon Dilation System

ACCLARENT, INC.

Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use

• Primary Device ID: 20705031465579
• NIH Device Record Key: ab564df3-9536-449b-9d39-7ed44ce78b51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCLARENT PIVOT
• Version Model Number: PVT0616L
• Catalog Number: PVT0616L
• 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
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• Phone: +1(650)687-5888
• Email: xxx@xxx.xxx
• 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.
• 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	10705031465572 [Primary]
GS1	20705031465579 [Package]; Contains: 10705031465572; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201115

FDA Product Code

• PNZ: Eustachian tube balloon dilation device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-09
• Device Publish Date: 2020-10-01

On-Brand Devices [ACCLARENT PIVOT]

• 20705031465616: ACCLARENT PIVOT Balloon Dilation System - 1PK
• 20705031465609: ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK
• 20705031465586: ACCLARENT PIVOT Illumination Balloon Dilation System - 1PK
• 20705031465593: ACCLARENT PIVOT Navigation Balloon Dilation System
• 20705031465579: ACCLARENT PIVOT Illumination Balloon Dilation System
• 20705031465562: ACCLARENT PIVOT Balloon Dilation System