SafeOp

Basic Information

• Brand Name: SafeOp
• Primary DI: 00190376459042
• Version / Model: AIX11812
• Company Name: ALPHATEC SPINE, INC.
• Labeler DUNS: 602465783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-12
• Public Version: 1
• Public Version Date: 2023-02-20
• Public Version Status: New
• Public Device Record Key: a8ca687f-d5fe-4c3e-bf78-bca51cc38567

Device Description

AIX Windows Tablet Power Supply

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKN	Electromyograph, diagnostic	Physical Medicine	890.1375	2
GXY	Electrode, cutaneous	Neurology	882.1320	2
GWF	Stimulator, electrical, evoked response	Neurology	882.1870	2
GXZ	ELECTRODE, NEEDLE	Neurology	882.1350	2
ETN	STIMULATOR, NERVE	Ear, Nose, Throat	874.1820	2
PDQ	Neurosurgical nerve locator	Ear, Nose, Throat	874.1820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46566	Neurophysiologic monitoring system	An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190376459042	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K213849	000