TetraGraph SEN 2001

GUDID 07350012440015

TetraGraph Neuromuscular Transmission Monitor

Senzime AB (Publ.)

Block-monitoring peripheral nerve electrical stimulation system

• Primary Device ID: 07350012440015
• NIH Device Record Key: d0facb52-3515-45d2-b3d4-e140233f2b63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TetraGraph
• Version Model Number: SEN 2001 TetraGraph monitor
• Catalog Number: SEN 2001
• Company DUNS: 559976316
• Company Name: Senzime AB (Publ.)
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

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	07350012440015 [Primary]

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 [TetraGraph]

• 07350012440015: TetraGraph Neuromuscular Transmission Monitor
• 07350012440237: TetraGraph Neuromuscular Transmission Monitor