StimRouter User Kit

GUDID 00815962020030

External Pulse Transmitter (EPT)

BIONESS INC.

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• Primary Device ID: 00815962020030
• NIH Device Record Key: ba2d7f00-9a90-4a0d-8959-4230fb82f98a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimRouter User Kit
• Version Model Number: ST2-5000
• Company DUNS: 182287727
• Company Name: BIONESS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142432

FDA Product Code

• GZF: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-19

On-Brand Devices [StimRouter User Kit]

• 00815962020030: External Pulse Transmitter (EPT)
• 00815962021464: External Electrical Field Conductor