TetraGraph Philips Interface SEN 2007

GUDID 07350012440107

TetraGraph Philip Interface (Optional to use with TetraGraph)

Senzime AB (Publ.)

Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system
Primary Device ID07350012440107
NIH Device Record Keya163cc1a-5a29-4ca0-8e75-98592077fe49
Commercial Distribution StatusIn Commercial Distribution
Brand NameTetraGraph Philips Interface
Version Model NumberTetraGraph Philips Interface
Catalog NumberSEN 2007
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 Batchfalse
Serial Numbertrue
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

Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
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
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107350012440107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-09-15
Device Publish Date2022-09-07

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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 Interface2022-09-15TetraGraph Philip Interface (Optional to use with TetraGraph)
07350012440107 - TetraGraph Philips Interface2022-09-15 TetraGraph Philip Interface (Optional to use with TetraGraph)
07350012440114 - TetraSens Pediatric2022-09-15 TetraSens Pediatric electrode
07350012440145 - TetraGraph Xcom2022-09-15 TetraGraph Xcom (Optional to use with TetraGraph)
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