TetraHub SEN 2017

GUDID 07350012440268

TetraHub (optional to use with TetraGraph SEN 2015)

Senzime AB (Publ.)

Block-monitoring peripheral nerve electrical stimulation system
Primary Device ID07350012440268
NIH Device Record Key9803e81a-6b96-4e5b-b552-bf23a422a9be
Commercial Distribution StatusIn Commercial Distribution
Brand NameTetraHub
Version Model NumberSEN 2017
Catalog NumberSEN 2017
Company DUNS559976316
Company NameSenzime AB (Publ.)
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107350012440268 [Primary]

FDA Product Code

KOIStimulator, Nerve, Peripheral, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-21
Device Publish Date2024-10-11

Devices Manufactured by Senzime AB (Publ.)

07350012440268 - TetraHub2024-10-21TetraHub (optional to use with TetraGraph SEN 2015)
07350012440268 - TetraHub2024-10-21 TetraHub (optional to use with TetraGraph SEN 2015)
07350012440237 - TetraGraph2024-10-11 TetraGraph Neuromuscular Transmission Monitor
07350012440176 - TetraSens2024-05-06 TetraSens with EZconnect
07350012440190 - TetraSens Pediatric2024-05-06 TetraSens Pediatric EZConnect
07350012440251 - TetraSensitive2024-05-06 TetraSensitive with EZconnect
00851540007161 - ExSpiron Pediatric PadSets2024-02-02 A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor fo
07350012440206 - TetraSensitive2023-11-14 TetraSensitive
07350012440107 - TetraGraph Philips Interface2022-09-15 TetraGraph Philip Interface (Optional to use with TetraGraph)

Trademark Results [TetraHub]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TETRAHUB
TETRAHUB
76542751 2874049 Live/Registered
Cypress Semiconductor Corporation
2003-09-08

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