| Primary Device ID | G373SEP2A0 |
| NIH Device Record Key | 1638a596-8ade-42fe-b024-74193aef358c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arms Medical |
| Version Model Number | SEP2A |
| Catalog Number | SEP2A |
| Company DUNS | 078579514 |
| Company Name | Zinnanti Surgical Design Group 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G373SEP2A0 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-08 |
| Device Publish Date | 2022-10-31 |
| G3731400030 - Zinnanti Surgical | 2024-06-11 6" Smoke Evac Fusion 3 mm Ball Tip |
| G3731415080 - Zinnanti Surgical | 2024-06-11 6" Smoke Evac Fusion 15mm x 8mm Loop |
| G3731420120 - Zinnanti Surgical | 2024-06-11 6" Smoke Evac Fusion 20mm 12mm Loop |
| G3731425100 - Zinnanti Surgical | 2024-06-11 6" Smoke Evac Fusion 25mm x 10mm Loop |
| G3731415120 - Zinnanti Surgical | 2024-02-05 6" Smoke Evac Fusion 15mm x 12mm Loop |
| G373141002P0 - Zinnanti Surgical | 2024-02-02 2" Smoke Evac Fusion Preferred Blade |
| G373141002PA0 - Zinnanti Surgical | 2024-02-02 2" Smoke Evac Fusion Plastics Blade |
| G373DM15120 - Diagnostic Medical | 2023-12-15 15mm x 12mm Loop |