SafeOp

GUDID 00190376189550

Tertiary Dilator

ALPHATEC SPINE, INC.

Neurophysiologic monitoring system

• Primary Device ID: 00190376189550
• NIH Device Record Key: dd4fa648-0979-464a-9096-7d98641342aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeOp
• Version Model Number: 100602
• 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: true
• 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
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376189550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191723

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190376189550]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-09
• Device Publish Date: 2019-12-01

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