StimRouter Electrode Set

GUDID 00815962020047

Electrode Set

BIONESS INC.

Analgesic PENS system probe, single-use

• Primary Device ID: 00815962020047
• NIH Device Record Key: 0a87ff9f-db12-40ba-b4c2-46d4f0e4cd7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimRouter Electrode Set
• Version Model Number: ST2-7000
• 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: true
• 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
• 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
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020047 [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: 3
• Public Version Date: 2018-06-11
• Device Publish Date: 2016-12-19

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