Altius Cuff Medium

GUDID 00810118490088

Neuros Medical, Inc.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

• Primary Device ID: 00810118490088
• NIH Device Record Key: 826243e7-b2c4-447f-a28b-04a8a09932e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altius Cuff Medium
• Version Model Number: FG-600-002
• Company DUNS: 829526081
• Company Name: Neuros Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118490088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230020

FDA Product Code

• SAZ: Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-31
• Device Publish Date: 2024-12-23

Devices Manufactured by Neuros Medical, Inc.

• 00810118490002 - Altius IPG: 2024-12-31
• 00810118490019 - Altius Battery Charger: 2024-12-31
• 00810118490026 - Altius Patient Controller: 2024-12-31
• 00810118490057 - Altius Programmer Wand: 2024-12-31
• 00810118490064 - Altius Programming Application PC: 2024-12-31
• 00810118490071 - Altius Cuff Small: 2024-12-31
• 00810118490088 - Altius Cuff Medium: 2024-12-31
• 00810118490088 - Altius Cuff Medium: 2024-12-31
• 00810118490095 - Altius Cuff Large: 2024-12-31