TetraGraph Pole Clamp kit SEN 2101

GUDID 07350012440091

TetraGraph Pole Clamp kit (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 ID07350012440091
NIH Device Record Key49a5f09f-b014-435f-8641-9299e4e5f75c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTetraGraph Pole Clamp kit
Version Model NumberSEN 2101 Pole Clamp for TetraGraph (Optional)
Catalog NumberSEN 2101
Company DUNS559976316
Company NameSenzime AB (Publ.)
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
GS107350012440091 [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 Date2020-05-01
Device Publish Date2020-04-23

Devices Manufactured by Senzime AB (Publ.)

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)
07350012440114 - TetraSens Pediatric2022-09-15 TetraSens Pediatric electrode
07350012440145 - TetraGraph Xcom2022-09-15 TetraGraph Xcom (Optional to use with TetraGraph)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.