Grason-Stadler

GUDID 00810046700495

Diagnostic Group LLC

Vestibulo-auditory analysis system

• Primary Device ID: 00810046700495
• NIH Device Record Key: 4dd58401-0ed6-434c-8a0d-d3e07a234ca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grason-Stadler
• Version Model Number: GSI Audera Pro
• Company DUNS: 175799717
• Company Name: Diagnostic Group LLC
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810046700495 [Primary]

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2020-11-04
• Device Publish Date: 2020-10-27

On-Brand Devices [Grason-Stadler]

• 00810046700495: GSI Audera Pro
• 00810046701690: GSI AMTAS Flex
• 08584270041069: GSI AudioStar Pro
• 00810046700488: GSI AudioStar Pro
• 00810046700273: GSI AMTAS Flex
• 00810046700266: GSI AMTAS Flex
• 00810046700235: GSI AMTAS Flex
• 00810046700129: GSI Novus
• 00810046700075: GSI Pello
• 00810046700006: GSI 18