Altius IPG

Basic Information

• Brand Name: Altius IPG
• Primary DI: 00810118490002
• Version / Model: FG-601-000
• Company Name: Neuros Medical, Inc.
• Labeler DUNS: 829526081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-23
• Public Version: 1
• Public Version Date: 2024-12-31
• Public Version Status: New
• Public Device Record Key: 40b73925-9978-44d9-99ce-093ff4850c6d

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SAZ	Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64970	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable	An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810118490002	GS1

Premarket Submissions

Submission Number	Supplement Number
P230020	000