| Primary Device ID | 00821925002661 |
| NIH Device Record Key | 4ca331f4-ea20-4afe-a9bc-814b62de45e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | USA Elite System™ and USA Series™ Cold Knife, Straight Blade |
| Version Model Number | K-SB |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, 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 | 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 |
| 00810008180983 - nCare | 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG |
| 00810008180990 - nCare | 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG |
| 00810008180501 - nCare | 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg |
| 00810008180921 - nCare | 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg |
| 00810008180952 - nCare | 2023-09-25 nCare, SNGL,DRCT SDI,DICOM |
| 00810008180969 - nCare | 2023-09-25 nCare, SNGL, ELA, DICOM |
| 00810008180976 - nCare | 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG |
| 00821925036406 - USA Elite | 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm) |