| Primary Device ID | 10653405001966 |
| NIH Device Record Key | 16f56b6d-e05a-45ed-afc2-a6f4ceb5cc09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HELIXAR |
| Version Model Number | 60-8432-001 |
| Catalog Number | 60-8432-001 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10653405001966 [Primary] |
| GEI | Electrosurgical, cutting & coagulation & accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-19 |
| Device Publish Date | 2021-02-11 |
| 20653405001970 | HELIXAR WIRELESS FOOTSWITCH KIT |
| 20653405005534 | HELIXAR ESU |
| 30653405001977 | HELIXAR WIRELESS FOOTSWITCH KIT |
| 30653405001960 | HELIXAR CART |
| 20653405001994 | HELIXAR STACKING ADAPTER FOR SYSTEM 5000 ELECTROSURGICAL UNIT STACKING ADAPTER |
| 20653405001987 | SMOKE KIT, HELIXAR AER DEFENSE DOOR ASSEMBLY |
| 20653405001963 | HELIXAR CART |
| 30653405000758 | HELIXAR:GENERATOR, CART, MONO F/S, BI F/S |
| 10653405001966 | HELIXAR CART |
| 10653405005537 | HELIXAR 100 - 240 VAC 50/60 HZ ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR |