BIOVENTUS ST2-4010

GUDID 06009880396443

The STIMPOD ST2-4010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-4010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle.

XAVANT TECHNOLOGY (PTY) LTD

Diagnostic peripheral nerve electrical stimulation system

• Primary Device ID: 06009880396443
• NIH Device Record Key: aa55dfeb-817f-4051-84dc-8fe17e6d11fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOVENTUS
• Version Model Number: STIMPOD ST2-4010
• Catalog Number: ST2-4010
• Company DUNS: 639571707
• Company Name: XAVANT TECHNOLOGY (PTY) LTD
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009880396443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140853

FDA Product Code

• BXN: Stimulator, Nerve, Battery-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-07
• Device Publish Date: 2025-07-30

Devices Manufactured by XAVANT TECHNOLOGY (PTY) LTD

• 06009880396443 - BIOVENTUS: 2025-08-07The STIMPOD ST2-4010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-4010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle.
• 06009880396443 - BIOVENTUS: 2025-08-07 The STIMPOD ST2-4010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrod
• 06009880396610 - STIMPOD X-LINK: 2025-08-07 The X-Link is intended to transmit data collected by the STIMPOD devices during NMT monitoring to a hospital's EMR (Electronic M
• 06009880396184 - BIONESS: 2025-02-25 The STIMPOD ST2-3000 is a nerve stimulation device designed to be used for the purpose of nerve locating using percutaneous elec
• 06009880396191 - BIONESS: 2025-02-25 The adapter cable is connected to the ST2-3000 nerve stimulation device for deploying electrical stimulations .
• 06009880396177 - STIMPOD: 2024-11-25 Neuromuscular blocking agent monitoring cable (3.0m) using electromyography. Accessory to be used with the STIMPOD NMS450 Nerve
• 06009880396429 - STIMPOD: 2024-11-25 Neuromuscular blocking agent monitoring cable (3.0m) using acceleromyography. Accessory to be used with the STIMPOD NMS450 Nerve
• 06009880396870 - Xavant Technology: 2024-01-01 The STIMPOD NMS450 is a Quantitative Neuromuscular Blockade monitor. The STIMPOD NMS 450 is also a precision nerve locating too
• 06009880396825 - Xavant Technology: 2023-11-20 The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulation device, used for symptomatic r