| Primary Device ID | 04260223140334 |
| NIH Device Record Key | 28a3e3d0-99cd-4984-b1d3-c3a87f6b4365 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 1077 EARTIP 6-9MM BLUE 100 PCS |
| Version Model Number | 8-68-34504 |
| 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 | 04260223140334 [Unit of Use] |
| GS1 | 04260223145339 [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 |
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| 04260223146572 - Ear Tip ET-LT40G Pack/100 pcs. | 2023-11-22 |
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| 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 |