SafeOp

GUDID 00190376234007

SafeOp EMG/NMJ Surface Electrode & SSEP Surface Electrode Procedure Kit

ALPHATEC SPINE, INC.

Electromyographic needle electrode, single-use
Primary Device ID00190376234007
NIH Device Record Key3c276425-6e7a-4204-81b4-9655f02318f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafeOp
Version Model NumberAIX1205A
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376234007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZELECTRODE, NEEDLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-08
Device Publish Date2019-12-31

On-Brand Devices [SafeOp]

00190376232300SafeOp Insulated Dilator Kit, Sterile
00190376232294SafeOp Stimulating Ball-Tip Probe, Sterile
00190376232287SafeOp Stimulating Clip, Sterile
00190376189550Tertiary Dilator
00190376189543Secondary Dilator
00190376189536Initial Dilator
00190376235493SafeOp Neural Informatix System Cable, Left Acquisition (Red)
00190376235486SafeOp Neural Informatix System Cable, Right Acquisition (White)
00190376234762SafeOp Head Unit Power Supply
00190376234755SafeOp Head Unit
00190376234007SafeOp EMG/NMJ Surface Electrode & SSEP Surface Electrode Procedure Kit
00190376233994SafeOp EMG/NMJ Needle Electrode & SSEP Surface Electrode Procedure Kit
00190376233987SafeOp EMG/NMJ Needle Electrode & SSEP Needle Electrode Procedure Kit
00190376233970SafeOp EMG/NMJ Surface Electrode Procedure Kit
00190376233963SafeOp EMG/NMJ Needle Electrode Procedure Kit
00190376192406SSEP Add-on Pack
00190376192390EMG/NMJ Base Pack
00190376192383SSEP Surface Electrode Kit
00190376192376EMG & NMJ Surface Electrodes Kit
00190376192277SafeOp Head Unit-A
00190376189154Right stimulator cable
00190376189147Left stimulator cable
00190376189130Right acquisition cable
00190376189123Left acquisition cable
00190376189116Stim and Acquisition Cable Kit
00190376180373EPAD2 tablet dock
00190376180359AIX Tablet Power Supply
00190376180342AIX Tablet
00190376180250SafeOp Probe and Clip Adapter
00190376235479SafeOp Neural Informatix System Cable, Left stimulator (Blue)
00190376235462SafeOp Neural Informatix System Cable, Right Stimulator (Yellow)
00190376218809SafeOp Neural Informatix System Cable, Left stimulator (Blue)
00190376331614SafeOp EMG/SSEP Harness
00190376331607SafeOp EMG Harness
00190376331591SafeOp White Recording Cable (2 Lead)
00190376330723SafeOp 1.5 Head Unit
00190376275796SafeOp EMG & SSEP Surface Electrode Kit
00190376275789SafeOp EMG & SSEP Needle Electrode Kit
00190376275772SafeOp EMG Surface Electrode Kit
00190376275765SafeOp EMG Needle Electrode Kit
00190376467832SafeOp Dual Surface Electrode 6-Pack
00190376460536SafeOp Dual Surface Electrode
00190376467825SafeOp Stimulating Dilator Kit, Sterile - Oval
00190376471358Tertiary Dilator, Plexus Map
00190376471341Secondary Dilator, Plexus Map
00190376471334Initial Dilator, Plexus Map
00190376459042AIX Windows Tablet Power Supply
00190376459035AIX Windows Tablet Docking Station
00190376459028AIX Windows Tablet
00190376458601AIX Windows Tablet Pole Clamp

Trademark Results [SafeOp]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAFEOP
SAFEOP
98094814 not registered Live/Pending
Alphatec Spine, Inc.
2023-07-20
SAFEOP
SAFEOP
75934007 2672642 Dead/Cancelled
HUBBELL INCORPORATED
2000-03-03

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