AccuScreen

GUDID 05713315008955

1077 AccuScreen ABR

Gn Otometrics A/S

Auditory stimulator

• Primary Device ID: 05713315008955
• NIH Device Record Key: 9815f802-3bd4-4cda-a1ec-7df5def2ec09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuScreen
• Version Model Number: 8-04-13964
• 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	05713315008955 [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