Brookstone

GUDID 30681066089584

Hearing aid, air-conduction, over the counter

Sakar International, Inc.

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 30681066089584
• NIH Device Record Key: 5a31dece-7df9-4568-9a0c-27ad0a95ad57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brookstone
• Version Model Number: BRH-007
• Company DUNS: 086413028
• Company Name: Sakar International, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681066089583 [Primary]
GS1	30681066089584 [Package]; Contains: 00681066089583; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• QUF: Hearing Aid, Air-Conduction, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-05
• Device Publish Date: 2023-09-27

On-Brand Devices [Brookstone]

• 30681066089614: Hearing aid, air-conduction, over the counter
• 30681066089607: Hearing aid, air-conduction with wireless technology, over the counter
• 30681066089591: Hearing aid, air-conduction with wireless technology, over the counter
• 30681066089584: Hearing aid, air-conduction, over the counter