GeniSurge
GUDID 00877972006534
GENICON, INC.
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use| Primary Device ID | 00877972006534 |
| NIH Device Record Key | f1233c42-82e0-4154-85bd-e1781f922775 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GeniSurge |
| Version Model Number | FX-533-005-925 |
| Company DUNS | 079805400 |
| Company Name | GENICON, 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00877972006534 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061417
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2017-10-11 |
On-Brand Devices [GeniSurge]
| 00877972007357 | FX-533-005-905 |
| 00877972006954 | 533-105-910T |
| 00877972006930 | 533-005-950T |
| 00877972006916 | 533-005-945T |
| 00877972006893 | 533-005-940T |
| 00877972006879 | 533-005-935T |
| 00877972006855 | 533-005-930T |
| 00877972006831 | 533-005-925T |
| 00877972006817 | 533-005-920T |
| 00877972006794 | 533-005-915T |
| 00877972006770 | 533-005-910T |
| 00877972006756 | 533-005-905T |
| 00877972006596 | FX-533-105-910 |
| 00877972006572 | FX-533-005-950 |
| 00877972006558 | FX-533-005-945 |
| 00877972006534 | FX-533-005-925 |
| 00877972006510 | FX-533-005-920 |
| 00877972006497 | FX-533-005-910 |
| 00877972004615 | 533-105-910 |
| 00877972002208 | 533-005-950 |
| 00877972002192 | 533-005-945 |
| 00877972002185 | 533-005-940 |
| 00877972002178 | 533-005-935 |
| 00877972002161 | 533-005-930 |
| 00877972002154 | 533-005-925 |
| 00877972002017 | 533-005-920 |
| 00877972002000 | 533-005-915 |
| 00877972001997 | 533-005-910 |
| 00877972001980 | 533-005-905 |
Trademark Results [GeniSurge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENISURGE 85870917 4414847 Live/Registered |
Genicon, LLC 2013-03-08 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.