| Primary Device ID | 04260223141492 |
| NIH Device Record Key | 26c86367-84d9-4f4b-ae50-2dac30435b2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sentiero Desktop Screening |
| Version Model Number | 100497-US3 |
| Company DUNS | 551540334 |
| Company Name | PATH medical GmbH |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260223141492 [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 | 2016-08-31 |
| 04260223141515 | Sentiero Desktop Screening Set US5 Screening OAE with Screening Tymp (IPSI&CONTRA) & Screening A |
| 04260223141508 | Sentiero Desktop Screening Set US4 Screening OAE with Screening Tymp (IPSI only) Content: 1. Sen |
| 04260223141492 | Sentiero Desktop Screening Set US3 Content: 1. Sentiero Desktop (Tymp Screening) AN100434-SB 2. |
| 04260223141485 | Sentiero Desktop Screening Set US2 Content: 1. Sentiero Desktop (Tymp Screening) AN100434-SB 2. |
| 04260223141478 | Sentiero Desktop Screening Set US1 Sentiero Desktop Screening Set Tymp with IPSI Reflex Content: |