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 |
Outer Diameter | 10 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00846430004146 [Primary] |
EWO | Audiometer |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-19 |
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Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SINGLE USE EARTIPS 75347628 not registered Dead/Abandoned |
Grason Associates, Inc. 1997-08-27 |