| Primary Device ID | 00385640000222 |
| NIH Device Record Key | 4f7ec162-36ca-4ead-9be4-6da97ec2fa41 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ear Pick Tip, 45 |
| Version Model Number | PX-1045 |
| Catalog Number | PX-1045 |
| 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 | 00385640000222 [Primary] |
| GS1 | 10385640000229 [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 |
| 00385640088510 - INSTRUSAFE | 2025-10-03 |
| 00385640088503 - INSTRUSAFE | 2025-10-01 |
| 00385640088480 - INSTRUSAFE | 2025-09-30 |
| 00385640088497 - INSTRUSAFE | 2025-09-30 |
| 00385640088466 - INSTRUSAFE | 2025-09-29 |
| 00385640088473 - INSTRUSAFE | 2025-09-29 |
| 00385640088398 - INSTRUSAFE | 2025-09-26 |
| 00385640088404 - INSTRUSAFE | 2025-09-26 |