FDA.reportPublic FDA data

TetraGraph Pole Clamp kit

Primary DI
07350012440091
Brand
TetraGraph Pole Clamp kit
Company
Senzime AB (Publ.)
Model
SEN 2101 Pole Clamp for TetraGraph (Optional)
Catalog number
SEN 2101
Device description
TetraGraph Pole Clamp kit (Optional to use with TetraGraph)
Published
2020-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOIStimulator, Nerve, Peripheral, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOIStimulator, Nerve, Peripheral, ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190795000Tetragraph Neuromuscular Transmission MonitorSenzime AB2019-10-18KOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350012440091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350012440091073500124400917350012440091

GMDN Terms#

Term, Definition table
TermDefinition
Block-monitoring peripheral nerve electrical stimulation systemAn assembly of battery-powered devices designed to apply electrical stimuli to a peripheral nerve (e.g., the ulnar or lower extremity nerve) to assess the adequacy of neuromuscular block during surgery, and its reversal during the recovery period. The system typically uses four kinds of stimulation: twitch, train-of-four, tetanic, and double burst. It typically includes conventional electrocardiographic electrodes and/or bipolar surface electrodes (ball electrodes), and a pulse generator.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2399204288info.us@senzime.com
800-213-1324info.us@senzime.com

Regulatory Flags#

DUNS number
559976316
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350012440268TetraHubSEN 2017SEN 20172024-10-11
07350012440237TetraGraphSEN 2015 TetraGraph monitorSEN 20152024-10-03
07350012440022TetraSensTetraSensSEN 20022020-04-23
07350012440121TetraSens PediatricSEN 2009 TetraSens PediatricSEN 20092022-09-07
07350012440169TetraSensSEN 2012 TetraSensSEN 20122024-04-26
07350012440183TetraSens PediatricSEN 2013 TetraSens PediatricSEN 20132024-04-26
07350012440244TetraSensitiveSEN 2016 TetraSensitiveSEN 20162024-04-26
00851540007161ExSpiron Pediatric PadSetsPediatricRMI-530402024-01-25
07350012440206TetraSensitiveSEN 2014 TetraSensitiveSEN 20142023-11-06
07350012440107TetraGraph Philips InterfaceTetraGraph Philips InterfaceSEN 20072022-09-07
07350012440145TetraGraph XcomSEN 2010 TetraGraph XcomSEN 20102022-09-07
07350012440015TetraGraphSEN 2001 TetraGraph monitorSEN 20012020-04-23
00851540007147ExSpiron 2XiRMI-540002020-01-06
00851540007048ExSpiron PadSetsAdultRMI-511102016-09-24
07350012440176TetraSensSEN 2012 TetraSensSEN 20122024-04-26
07350012440190TetraSens PediatricSEN 2013 TetraSens PediatricSEN 20132024-04-26
07350012440251TetraSensitiveSEN 2016 TetraSensitiveSEN 20162024-04-26
07350012440114TetraSens PediatricSEN 2009 TetraSens PediatricSEN 20092022-09-07
07350012440039TetraSensTetraSensSEN 20022020-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyKOI2026-04-15
03665023000535WiTOFIDMEDKOI2025-12-19
03665023000542WiTOFIDMEDKOI2025-12-19
03665023000559WiTOFIDMEDKOI2025-12-19
03665023000566WiTOFIDMEDKOI2025-12-19
03665023000573WiTOFIDMEDKOI2025-12-19
03665023000610WiTOFIDMEDKOI2025-12-19
04255629200751Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2025-11-21
00860012119660iTOFNERBIO PRIVATE LIMITEDKOI2025-02-05
00850023319005TwitchView Medium ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
00850023319029TwitchView™BLINK DEVICE COMPANYKOI2024-11-07
00850023319036TwitchView Small ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
00850023319098TwitchView2 MonitorBLINK DEVICE COMPANYKOI2024-11-07
00850023319104TwitchView2 Charging DockBLINK DEVICE COMPANYKOI2024-11-07
00850023319111TwitchView2 Patient Cable 14'BLINK DEVICE COMPANYKOI2024-11-07
00850023319173TwitchView2 Patient Cable 20'BLINK DEVICE COMPANYKOI2024-11-07
00850023319180TwitchView Large ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
07350012440268TetraHubSenzime AB (Publ.)KOI2024-10-11
07350012440237TetraGraphSenzime AB (Publ.)KOI2024-10-03
07350012440169TetraSensSenzime AB (Publ.)KOI2024-04-26
07350012440183TetraSens PediatricSenzime AB (Publ.)KOI2024-04-26
07350012440244TetraSensitiveSenzime AB (Publ.)KOI2024-04-26
07350012440176TetraSensSenzime AB (Publ.)KOI2024-04-26
07350012440190TetraSens PediatricSenzime AB (Publ.)KOI2024-04-26
07350012440251TetraSensitiveSenzime AB (Publ.)KOI2024-04-26
07350012440206TetraSensitiveSenzime AB (Publ.)KOI2023-11-06
04255629200904EPSIMEDEPSIMED LLCKOI2023-10-25
04255629200423Eye adapter TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200454Thumb adapter TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200393TOF3D - Neuromuscular Transmission MonitorMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10