| Primary Device ID | 04260223140617 |
| NIH Device Record Key | de8db6ed-3487-46e0-8858-6aad5afede14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 1077 EARTIP 8-11 TRANS 100 PCS |
| Version Model Number | 8-68-34510 |
| Company DUNS | 551540334 |
| Company Name | PATH medical GmbH |
| Device Count | 100 |
| 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 | false |
| Serial Number | false |
| 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 | 04260223140617 [Unit of Use] |
| GS1 | 04260223145353 [Primary] |
| GWJ | Stimulator, Auditory, Evoked Response |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-06 |
| Device Publish Date | 2020-06-27 |
| 04260223142994 - Sentiero Desktop Diagnostic | 2024-05-30 Sentiero Desktop Set Diagnostic Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe E |
| 04260223147210 - Ear Tip PM009H Pack/100 pcs. | 2024-05-30 9 mm mushroom ear tip, hard version |
| 04260223147227 - Ear Tip PM010H Pack/100 pcs. | 2024-05-30 10 mm mushroom ear tip, hard version |
| 04260223146572 - Ear Tip ET-LT40G Pack/100 pcs. | 2023-11-22 |
| 04260223146596 - Ear Tip ET-LT45G Pack/100 pcs. | 2023-11-22 |
| 04260223146619 - Ear Tip ET-LT50G Pack/100 pcs. | 2023-11-22 |
| 04260223146633 - Ear Tip ET-LT60M Pack/100 pcs. | 2023-11-22 |
| 04260223146978 - Ear Tip PM007H Pack/100 pcs. | 2023-11-22 7 mm mushroom ear tip, hard version |