Tweak

GUDID 00810323009631

Over the counter air conduction hearing aid

EAR TECHNOLOGY CORPORATION

Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 00810323009631
• NIH Device Record Key: 6c10f7bf-dcc2-42fb-9968-8eff1ec66c96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tweak
• Version Model Number: Focus+T otc
• Company DUNS: 023930584
• Company Name: EAR TECHNOLOGY CORPORATION
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com
• Phone: 1-800-327-8547
• Email: sstahmer@eartech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810323009631 [Primary]

FDA Product Code

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

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: 2023-08-22
• Device Publish Date: 2023-08-14

Devices Manufactured by EAR TECHNOLOGY CORPORATION

• 00810323000003 - LightBeam: 2024-02-08 50 Pieces of Lighted Tamper Curette
• 00810323009631 - Tweak: 2023-08-22Over the counter air conduction hearing aid
• 00810323009631 - Tweak: 2023-08-22 Over the counter air conduction hearing aid
• 00810323001918 - LightBeam: 2023-06-09 50 Pieces of Lighted Large Circle Loop Curettte
• 00810323001840 - LightBeam: 2022-05-17 50 pieces of Lighted Small Tri-Loop Curette
• 00810323001857 - LightBeam: 2022-05-17 50 Pieces of Lighted Large Circle Loop Curettte
• 00810323001864 - LightBeam: 2022-05-17 50 Pieces of Lighted Large Spoon Curette
• 00810323001871 - LightBeam: 2022-05-17 50 pieces of Lighted Small Circle Loop Curette
• 00810323001888 - LightBeam: 2022-05-17 50 pieces of Lighted Narrow Spoon Curette