| Primary Device ID | 10888551024389 |
| NIH Device Record Key | 197b0af3-8039-4d64-affa-b694191f8c41 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SYN395.782 |
| Catalog Number | SYN395.782 |
| Company DUNS | 175899459 |
| Company Name | STERILMED, INC. |
| Device Count | 1 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(888)541-0078 |
| customerservice@sterilmed.com | |
| Phone | +1(888)541-0078 |
| customerservice@sterilmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888551024389 [Primary] |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-22 |
| 10888551045179 - NA | 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE |
| 10888551045186 - NA | 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE |
| 10888551045193 - NA | 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE |
| 10888551045209 - NA | 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE |
| 10888551010313 - NA | 2021-01-22 KNIFE SET ECTRA II (PACK OF 3) |
| 10888551021531 - NA | 2021-01-22 KNIVES (1) HOOK BLADE (1) TRIANGLE BLADE ENDOTRAC BLADE SYSTEM |
| 10888551000048 - NA | 2020-11-06 CTS RELIEF KIT, 5PC SET |
| 10888551012928 - NA | 2020-10-19 ENDO LUNG |