Tremetrics

GUDID 08584270041106

Diagnostic Group LLC

Tone audiometer

• Primary Device ID: 08584270041106
• NIH Device Record Key: 4b1dd487-f71f-4798-8664-588727ad983a
• Commercial Distribution Discontinuation: 2020-05-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tremetrics
• Version Model Number: RA800
• Company DUNS: 175799717
• Company Name: Diagnostic Group LLC
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08584270041106 [Primary]

FDA Product Code

• EWO: Audiometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-08-03
• Device Publish Date: 2016-11-10

On-Brand Devices [Tremetrics]

• 08584270041731: HT Wizard PC
• 08584270041724: RA650
• 08584270041328: HT Wizard Ultra
• 08584270041311: RA300
• 08584270041106: RA800