| Primary Device ID | 00846430004191 |
| NIH Device Record Key | 1af92b96-86ad-44fb-b9e0-3c2913e0dfc1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Use Eartip |
| Version Model Number | ER10D-T16 |
| 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 |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846430004191 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-19 |
| 00846430004191 | Eartip 16mm 100pk |
| 00846430004184 | Eartip 14mm 100pk |
| 00846430004177 | Eartip 13mm 100pk |
| 00846430004160 | Eartip 12mm 100pk |
| 00846430004153 | Eartip 11mm 100pk |
| 00846430004139 | 9mm Single Use Ear tip 100pk |
| 00846430004122 | 8mm single use eartip 100pk |
| 00846430004115 | 7mm Single Use Ear tip 100pk |
| 00846430004108 | 6mm Single Use Ear tip 100pk |
| 00846430004092 | 5mm Single Use Eartip 100pk |
| 00846430004085 | 4mm Ear tip 100pk |
| 00846430004078 | 3mm Single Use Eartip 100pk |