| Primary Device ID | 04260223143182 |
| NIH Device Record Key | f62b17ac-9ee6-48d0-b528-f567f41236ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ear Tip IT-01 Pack/100 pcs. |
| Version Model Number | 100898-100 |
| 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 | 04260223143168 [Unit of Use] |
| GS1 | 04260223143182 [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 | 2019-09-24 |
| Device Publish Date | 2018-06-01 |
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| 04260223146985 - Ear Tip PM011H Pack/100 pcs. | 2023-11-22 11 mm mushroom ear tip, hard version |
| 04260223146992 - Ear Tip PM012H Pack/100 pcs. | 2023-11-22 12 mm mushroom ear tip, hard version |
| 04260223147005 - Ear Tip PM013H Pack/100 pcs. | 2023-11-22 13 mm mushroom ear tip, hard version |