TetraSens SEN 2002

GUDID 07350012440039

TetraSens TetraGraph Electrode

Senzime AB (Publ.)

Block-monitoring peripheral nerve electrical stimulation system

• Primary Device ID: 07350012440039
• NIH Device Record Key: 9efb9cdb-7124-4fa4-8993-61ef30caa484
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TetraSens
• Version Model Number: TetraSens
• Catalog Number: SEN 2002
• Company DUNS: 559976316
• Company Name: Senzime AB (Publ.)
• 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: false
• 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

Customer Support Contacts

• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350012440022 [Primary]
GS1	07350012440039 [Package]; Contains: 07350012440022; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190795

FDA Product Code

• KOI: Stimulator, Nerve, Peripheral, Electric

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: 2020-05-01
• Device Publish Date: 2020-04-23

On-Brand Devices [TetraSens]

• 07350012440039: TetraSens TetraGraph Electrode
• 07350012440176: TetraSens with EZconnect