Single Use Eartips
GUDID 00846430004146
Eartip 10mm 100pkg
ETYMOTIC RESEARCH, INC.
Audiometric ear tip| Primary Device ID | 00846430004146 |
| NIH Device Record Key | 11ec0517-2536-4f0c-a049-d5ec8f0bf4e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Use Eartips |
| Version Model Number | ER10D-T10 |
| Company DUNS | 115380859 |
| Company Name | ETYMOTIC RESEARCH, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | true |
Device Dimensions
| Outer Diameter | 10 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846430004146 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K930553
FDA Product Code
| EWO | Audiometer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
Devices Manufactured by ETYMOTIC RESEARCH, INC.
| 00846430005846 - Lucid Audio | 2024-11-07 TALA Android EARPIECE LEFT |
| 00846430005853 - Lucid Audio | 2024-11-07 TALA Android EARPIECE RIGHT |
| 00846430005877 - Lucid Audio | 2024-11-07 Tala MFI Earpiece LEFT |
| 00846430005884 - Lucid Audio | 2024-11-07 Tala MFI Earpiece RIGHT |
| 00846430006003 - Lucid Audio | 2024-08-27 Accent Bluetooth rechargeable 1401 - Android WH - 32 channel *Sam's Club 20218 |
| 00846430006010 - Lucid Audio | 2024-08-27 Accent Bluetooth rechargeable 1501 - MFI WH - 32 channel *Sam's Club 20219 |
| 00846430005693 - Lucid Audio | 2024-02-29 Lucid Hearing Outdoors Hearing Protection #20058 |
| 00846430005709 - Lucid Audio | 2024-02-29 Lucid Hearing Motorsports Hearing Protection #20059 |
Trademark Results [Single Use Eartips]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SINGLE USE EARTIPS 75347628 not registered Dead/Abandoned |
Grason Associates, Inc. 1997-08-27 |
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