SafeOp
GUDID 00190376192383
SSEP Surface Electrode Kit
ALPHATEC SPINE, INC.
Transcutaneous electrical stimulation electrode| Primary Device ID | 00190376192383 |
| NIH Device Record Key | e601b822-07f5-4365-bcbb-9cb8dd7675d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafeOp |
| Version Model Number | 200525-SS |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376192383 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182542
FDA Product Code
| GXY | ELECTRODE, CUTANEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-08 |
| Device Publish Date | 2019-12-31 |
On-Brand Devices [SafeOp]
| 00190376232300 | SafeOp Insulated Dilator Kit, Sterile |
| 00190376232294 | SafeOp Stimulating Ball-Tip Probe, Sterile |
| 00190376232287 | SafeOp Stimulating Clip, Sterile |
| 00190376189550 | Tertiary Dilator |
| 00190376189543 | Secondary Dilator |
| 00190376189536 | Initial Dilator |
| 00190376235493 | SafeOp Neural Informatix System Cable, Left Acquisition (Red) |
| 00190376235486 | SafeOp Neural Informatix System Cable, Right Acquisition (White) |
| 00190376234762 | SafeOp Head Unit Power Supply |
| 00190376234755 | SafeOp Head Unit |
| 00190376234007 | SafeOp EMG/NMJ Surface Electrode & SSEP Surface Electrode Procedure Kit |
| 00190376233994 | SafeOp EMG/NMJ Needle Electrode & SSEP Surface Electrode Procedure Kit |
| 00190376233987 | SafeOp EMG/NMJ Needle Electrode & SSEP Needle Electrode Procedure Kit |
| 00190376233970 | SafeOp EMG/NMJ Surface Electrode Procedure Kit |
| 00190376233963 | SafeOp EMG/NMJ Needle Electrode Procedure Kit |
| 00190376192406 | SSEP Add-on Pack |
| 00190376192390 | EMG/NMJ Base Pack |
| 00190376192383 | SSEP Surface Electrode Kit |
| 00190376192376 | EMG & NMJ Surface Electrodes Kit |
| 00190376192277 | SafeOp Head Unit-A |
| 00190376189154 | Right stimulator cable |
| 00190376189147 | Left stimulator cable |
| 00190376189130 | Right acquisition cable |
| 00190376189123 | Left acquisition cable |
| 00190376189116 | Stim and Acquisition Cable Kit |
| 00190376180373 | EPAD2 tablet dock |
| 00190376180359 | AIX Tablet Power Supply |
| 00190376180342 | AIX Tablet |
| 00190376180250 | SafeOp Probe and Clip Adapter |
| 00190376235479 | SafeOp Neural Informatix System Cable, Left stimulator (Blue) |
| 00190376235462 | SafeOp Neural Informatix System Cable, Right Stimulator (Yellow) |
| 00190376218809 | SafeOp Neural Informatix System Cable, Left stimulator (Blue) |
| 00190376331614 | SafeOp EMG/SSEP Harness |
| 00190376331607 | SafeOp EMG Harness |
| 00190376331591 | SafeOp White Recording Cable (2 Lead) |
| 00190376330723 | SafeOp 1.5 Head Unit |
| 00190376275796 | SafeOp EMG & SSEP Surface Electrode Kit |
| 00190376275789 | SafeOp EMG & SSEP Needle Electrode Kit |
| 00190376275772 | SafeOp EMG Surface Electrode Kit |
| 00190376275765 | SafeOp EMG Needle Electrode Kit |
| 00190376467832 | SafeOp Dual Surface Electrode 6-Pack |
| 00190376460536 | SafeOp Dual Surface Electrode |
| 00190376467825 | SafeOp Stimulating Dilator Kit, Sterile - Oval |
| 00190376471358 | Tertiary Dilator, Plexus Map |
| 00190376471341 | Secondary Dilator, Plexus Map |
| 00190376471334 | Initial Dilator, Plexus Map |
| 00190376459042 | AIX Windows Tablet Power Supply |
| 00190376459035 | AIX Windows Tablet Docking Station |
| 00190376459028 | AIX Windows Tablet |
| 00190376458601 | AIX Windows Tablet Pole Clamp |
Trademark Results [SafeOp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAFEOP 98094814 not registered Live/Pending |
Alphatec Spine, Inc. 2023-07-20 |
 SAFEOP 75934007 2672642 Dead/Cancelled |
HUBBELL INCORPORATED 2000-03-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.