Altius IPG Accessory Kit

Basic Information

• Brand Name: Altius IPG Accessory Kit
• Primary DI: 00810118490101
• Version / Model: FG-610-000
• Company Name: Neuros Medical, Inc.
• Labeler DUNS: 829526081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-23
• Public Version: 1
• Public Version Date: 2025-07-01
• Public Version Status: New
• Public Device Record Key: 9596708e-4676-4c79-931b-ab6eecc4903a

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
44900	Implantable pulse generator port plug	A non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials; disposable devices intended to facilitate connection/stabilisation (e.g., torque wrench) may be included with the port plug.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810118490101	GS1

Premarket Submissions

Submission Number	Supplement Number
P230020	000