UGS TEOAE General Purpose Probe

GUDID 05060396170294

OTODYNAMICS LIMITED

Otoacoustic emission system, line-powered

• Primary Device ID: 05060396170294
• NIH Device Record Key: d6810056-20bb-4db6-bc14-6517d75f1425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UGS TEOAE General Purpose Probe
• Version Model Number: PR-UGD
• Company DUNS: 235908050
• Company Name: OTODYNAMICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060396170294 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-11

On-Brand Devices [UGS TEOAE General Purpose Probe]

• 05060396170294: PR-UGD
• 05060396170287: PR-UGS