ACCLARENT AERA EU061655Z

GUDID 20705031230870

ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 1 PK

ACCLARENT, INC.

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

• Primary Device ID: 20705031230870
• NIH Device Record Key: 79d2130d-ac33-415a-b8e5-6ae32252bd73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCLARENT AERA
• Version Model Number: EU061655Z
• Catalog Number: EU061655Z
• 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(877)775-2789
• Email: xx@xx.xx
• Phone: +1(877)775-2789
• Email: xx@xx.xx

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705031230870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150056

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-11-05

On-Brand Devices [ACCLARENT AERA]

• 20705031230870: ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 1 PK
• 20705031230887: ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM