Interacoustics
GUDID 05711117190823
Interacoustics A/S
Otoacoustic emission system, battery-powered| Primary Device ID | 05711117190823 |
| NIH Device Record Key | 514687c4-2ca9-41df-a44d-fdbdc7a22573 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Interacoustics |
| Version Model Number | Sera |
| Company DUNS | 306308354 |
| Company Name | Interacoustics 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 | 05711117190823 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173567
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 | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-23 |
On-Brand Devices [Interacoustics]
| 05711117195989 | VisualEyes 505 |
| 05711117190823 | Sera |
| 05711117180565 | EyeSeeCam |
| 05711117180558 | VisualEyes 525 |
| 05711117180459 | OtoRead |
| 05711117180329 | AA222 |
| 05711117180305 | PA5 |
| 05711117180268 | Equinox 2.0 |
| 05711117180251 | AT235 |
| 05711117180244 | AS608 |
| 05711117180213 | AD226 |
| 05711117180206 | AC40 |
| 05711117101621 | AD629 |
| 05711117089189 | Callisto |
| 05711117082104 | Titan |
| 05711117076677 | Eclipse |
| 05711117070736 | Affinity 2.0 |
| 05711117197877 | Audiometer |
| 05711117196313 | Lyra |
| 05711117219098 | TRV |
| 05711117223095 | Luna |
| 05711117180541 | VisualEyes 515 |
| 05711117180497 | 2D-VOGfw |
| 05711117180282 | MT10 |
| 05711117199567 | Air Fx |
| 05711117199574 | Aqua Stim |
| 05711117225853 | Vorteq |
| 05711117199765 | Viot Suite |
| 05711117198218 | Affinity Compact |
Trademark Results [Interacoustics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERACOUSTICS 79033849 3436244 Live/Registered |
Interacoustics A/S 2006-07-14 |
 INTERACOUSTICS 73653910 1464435 Live/Registered |
INTERACOUSTICS A/S 1987-04-08 |
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