Go Prime - Beige

GUDID 00850022464591

Go Prime - Beige - In-store

HEARX GROUP (PTY) LTD

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00850022464591
• NIH Device Record Key: 52fdbf6a-ba94-4d86-8b8c-b018b195923c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Go Prime - Beige
• Version Model Number: Go Hearing
• Company DUNS: 539177681
• Company Name: HEARX GROUP (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00850022464591 [Primary]

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: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [Go Prime - Beige]

• 00850022464591: Go Prime - Beige - In-store
• 00810153660187: Go Prime - Beige - In-store