AccuScreen

GUDID 05713315008979

1077 AccuScreen ABR/DP

Gn Otometrics A/S

Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator

• Primary Device ID: 05713315008979
• NIH Device Record Key: eba28203-5b2f-49f0-8b63-c143380d506f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuScreen
• Version Model Number: 8-04-13966
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• 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	05713315008979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132957

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: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [AccuScreen]

• 05713315008849: 1077 AccuScreen ABR
• 05713315008832: 1077 AccuScreen TE/DP
• 05713315008825: 1077 AccuScreen DP
• 05713315008818: 1077 AccuScreen TE
• 05713315008948: 1077 AccuScreen TE/DP
• 05713315008931: 1077 AccuScreen DP
• 05713315008924: 1077 AccuScreen TE
• 05713315008917: 1077 AccuScreen DP
• 05713315008900: 1077 AccuScreen Lite DP
• 05713315008894: 1077 AccuScreen Lite DP
• 05713315008887: 1077 AccuScreen Lite TE
• 05713315008870: 1077 AccuScreen ABR/TE/DP
• 05713315008863: 1077 AccuScreen ABR/DP
• 00571331500885: 1077 AccuScreen ABR/TE
• 05713315009006: 1077 AccuScreen Service Tool CD
• 05713315008993: 1077 AccuScreen ABR
• 05713315008986: 1077 AccuScreen ABR/TE/DP
• 05713315008979: 1077 AccuScreen ABR/DP
• 05713315008962: 1077 AccuScreen ABR/TE
• 05713315008955: 1077 AccuScreen ABR