TetraSensitive SEN 2016

GUDID 07350012440251

TetraSensitive with EZconnect

Senzime AB (Publ.)

Block-monitoring peripheral nerve electrical stimulation system

• Primary Device ID: 07350012440251
• NIH Device Record Key: 62ec805d-dfc8-40e6-9858-f505b181aaf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TetraSensitive
• Version Model Number: SEN 2016 TetraSensitive
• Catalog Number: SEN 2016
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350012440244 [Primary]
GS1	07350012440251 [Package]; Contains: 07350012440244; Package: Box [15 Units]; In Commercial Distribution

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: 2024-05-06
• Device Publish Date: 2024-04-26

On-Brand Devices [TetraSensitive]

• 07350012440206: TetraSensitive
• 07350012440251: TetraSensitive with EZconnect