| Primary Device ID | 10385640086803 |
| NIH Device Record Key | 2e1386fd-c726-451d-af40-0e6e1a2f1d8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUMMIT MEDICAL |
| Version Model Number | LS2000 |
| Company DUNS | 965484699 |
| Company Name | Summit Medical, Inc. |
| Device Count | 12 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640086806 [Unit of Use] |
| GS1 | 10385640086803 [Package] Package: Box [10 Units] In Commercial Distribution |
| KDQ | Bottle, Collection, Vacuum |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-25 |
| Device Publish Date | 2025-07-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUMMIT MEDICAL 76311856 3043090 Live/Registered |
SUMMIT MEDICAL LIMITED 2001-09-12 |
![]() SUMMIT MEDICAL 74676630 2038183 Dead/Cancelled |
Summit Medical Systems, Inc. 1995-05-16 |