| Primary Device ID | 00385640000215 |
| NIH Device Record Key | 92cb1009-8e9d-4e99-b551-4fcfed83b13e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ear Pick Tip, Straight |
| Version Model Number | PX-1000 |
| Catalog Number | PX-1000 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640000215 [Primary] |
| GS1 | 10385640000212 [Package] Package: Box [6 Units] In Commercial Distribution |
| JYT | Pick, Microsurgical Ear |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-09 |
| 00385640080798 - INSTRUSAFE | 2024-04-25 |
| 00385640080804 - INSTRUSAFE | 2024-04-25 |
| 00385640080774 - INSTRUSAFE | 2024-04-24 |
| 00385640080781 - INSTRUSAFE | 2024-04-24 |
| 00385640017954 - INSTRUSAFE | 2024-04-22 |
| 00385640080712 - INSTRUSAFE | 2024-04-19 |
| 00385640080729 - INSTRUSAFE | 2024-04-19 |
| 00385640080736 - INSTRUSAFE | 2024-04-19 |