GN Otometrics A/S 8-04-16046

GUDID 05713315005657

Gn Otometrics A/S

Impedance audiometer

• Primary Device ID: 05713315005657
• NIH Device Record Key: ca269055-7757-41a6-ba94-67b01a5a7a9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GN Otometrics A/S
• Version Model Number: 1096, SA,CLINI W/ PRIN, CLAS US
• Catalog Number: 8-04-16046
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315005657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161707

FDA Product Code

• ETY: Tester, Auditory Impedance

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-02

On-Brand Devices [GN Otometrics A/S]

• 05713315008184: OTOair 2 Bluetooth Dongle
• 05713315006005: 1093, Headset HS3
• 05713315005886: 1093, Otoscan Instrument
• 05713315005701: REM Tube with ruler
• 05713315005688: 1096, SA CLINI W/O PRIN,CLAS US
• 05713315005671: 1096, SA,CLINI W/O PRIN, COM US
• 05713315005664: 1096, SA CLINI W/ PRIN,COM US
• 05713315005657: 1096, SA,CLINI W/ PRIN, CLAS US
• 05713315005640: 1096, SA,DIAG W/O PRIN,CLASS US
• 05713315005633: 1096,SA, DIAG W/O PRIN,COM US
• 05713315005626: 1096,SA, DIAG W/ PRIN,CLASS US
• 05713315005619: 1096,SA, DIAG W/ PRIN, COM US
• 05713315005602: 1096,SA, QUICKCHECK W/ PRIN, US
• 05713315005596: 1096,SA, QUICKCHECK W/O PRIN, US
• 05713315005589: 1096, PC CLINICAL COM US
• 05713315005572: 1096, PC CLINICAL CLAS US
• 05713315005565: 1096, PC, DIAGNOSTIC, CLASS, US
• 05713315005558: 1096, PC, DIAGNOSTIC, COM, US
• 05713315005541: 1096, PC, QUICKCHECK, US
• 05713315005534: 1081 AURICAL w/o HI-PRO
• 05713315005527: 1081 AURICAL with HI-PRO
• 05713315005497: MADSEN AccuScreen, TE/DP
• 05713315005480: MADSEN AccuScreen, DP
• 05713315005473: MADSEN AccuScreen, TE
• 05713315005466: NB71, Boneconductor w/headband and cable
• 05713315005459: 1004, DIN TO JACK MALE ADAPTER
• 05713315005442: ECC for EarHugs
• 05713315005435: 1021, EAR TIP KIT,16 MM 50PCS
• 05713315005428: 1021, EAR TIP KIT,12,5MM 50PCS
• 05713315005411: 1021, EAR TIP KIT, 11MM 50PCS
• 05713315005404: 1021, EAR TIP KIT, 9.5MM 50PCS
• 05713315005398: 1021, EAR TIP KIT, 8MM 50PCS
• 05713315005374: 1021, EAR TIP KIT, 6MM 50PCS
• 05713315005367: 1021, EAR TIP KIT, 5MM 50PCS
• 05713315005343: AS, TEST CAVITY, 1.75 CCM
• 05713315005336: Earhugs, disposables
• 05713315005282: 1085, VOLUME VISION DENIED BOX
• 05713315005268: 1085, GOGGLE HOME KIT
• 05713315005244: 1085 Vision Denied Solution Kit (50 sets)
• 05713315005183: 1096, INSERT CONTRA PHONE
• 05713315005176: 1096, CONTRA TDH39
• 05713315005169: 1096, EARTIP STARTER KIT
• 05713315005152: 1096, PROBE TIP KIT
• 05713315005145: 1096, CALIBRATION CAVITY KIT
• 05713315005138: 1096, 2CC TEST CAVITY
• 05713315005121: 1096, DIAGNOSTIC PROBE,COMFORT
• 05713315005114: 1096, DIAGNOSTIC PROBE,CLASSIC
• 05713315005107: 1096, QUICK CHECK PROBE
• 05713315005091: 1078, EARTIP STARTER KIT
• 05713315005084: ENG CBL,7-LD,USED W/O PREAMP