FDA.reportPublic FDA data

TetraSensitive

Primary DI
07350012440206
Brand
TetraSensitive
Company
Senzime AB (Publ.)
Model
SEN 2014 TetraSensitive
Catalog number
SEN 2014
Device description
TetraSensitive
Published
2023-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350012440213PackageGS115In Commercial Distribution
07350012440206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350012440213073500124402137350012440213
07350012440206073500124402067350012440206

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
559976316
Device count
1
Lot or batch
true
Expiration date on label
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
07350012440107TetraGraph Philips InterfaceTetraGraph Philips InterfaceSEN 20072022-09-07
07350012440145TetraGraph XcomSEN 2010 TetraGraph XcomSEN 20102022-09-07
07350012440015TetraGraphSEN 2001 TetraGraph monitorSEN 20012020-04-23
07350012440091TetraGraph Pole Clamp kitSEN 2101 Pole Clamp for TetraGraph (Optional)SEN 21012020-04-23
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
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
04255629200409Temperature sensor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10