FDA.reportPublic FDA data

Temena

Primary DI
03700339716395
Brand
Temena
Company
Temena GmbH
Model
27050-01
Catalog number
27050-01
Device description
Peripheral Nerve Block Stimulator
Published
2017-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXNStimulator, Nerve, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXNStimulator, Nerve, Battery-PoweredAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700339716395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700339716395037003397163953700339716395

GMDN Terms#

Term, Definition table
TermDefinition
Intramuscular injection site nerve-locating/electromyography systemA portable, electrically-powered device intended to produce electrical impulses for electrical nerve stimulation and to obtain and display electromyography (EMG) readings (visual and/or audio) to locate nerves and muscle, to facilitate accurate intramuscular injection of neuromodulator drugs. It is typically used in multi-focal areas (e.g., neck, hand), and consists of an electrical stimulator with EMG reader in a noninvasive unit (electrodes not included) which typically includes input cables and connectors.

Regulatory Flags#

DUNS number
329515725
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700339710140Temena01950-2001950-202017-11-28
03700339710157Temena01950-2201950-222017-11-28
03700339710164Temena01950-2401950-242017-11-20
03700339710171Temena01950-2501950-252017-11-28
03700339710188Temena01950-2601950-262017-11-20
03700339710195Temena01950-2701950-272017-11-28
03700339711291Temena21950-2221950-222017-11-28
03700339711307Temena21950-2421950-242017-11-20
03700339711314Temena21950-2521950-252017-11-28
03700339711321Temena21950-2621950-262017-11-28
03700339711338Temena21950-2721950-272017-11-28
03700339711345Temena21950-2921950-292017-11-28
03700339711352Temena21951-2221951-222017-11-20
03700339711369Temena21951-2421951-242017-11-28
03700339711383Temena21951-2621951-262017-11-28
03700339711390Temena21951-2721951-272017-11-28
03700339711550Temena29922-2729922-272017-11-29
03700339711598Temena31922-2731922-272017-11-29
03700339711604Temena31940-2231940-222017-11-28
03700339711611Temena31940-2431940-242017-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223126103NerveStim PurePajunk GmbH MedizintechnologieBXN2026-02-06
06009880396443BIOVENTUSXAVANT TECHNOLOGY (PTY) LTDBXN2025-07-30
06009880396184BIONESSXAVANT TECHNOLOGY (PTY) LTDBXN2025-02-17
06009880396191BIONESSXAVANT TECHNOLOGY (PTY) LTDBXN2025-02-17
04048223093931ExtensionCable 60cmPajunk GmbH MedizintechnologieBXN2025-01-30
04048223103784ExtensionCable 60cmPajunk GmbH MedizintechnologieBXN2025-01-30
06009880396177STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2024-11-15
06009880396429STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2024-11-15
06009880396870Xavant TechnologyXAVANT TECHNOLOGY (PTY) LTDBXN2023-12-23
10889483000014SunMedSUNMED, LLCBXN2023-08-01
10889483171127SunMedSUNMED, LLCBXN2023-08-01
10889483171394SunMedSUNMED, LLCBXN2023-08-01
10889483171417SunMedSUNMED, LLCBXN2023-08-01
10889483171424SunMedSUNMED, LLCBXN2023-08-01
10889483171431SunMedSUNMED, LLCBXN2023-08-01
10889483171448SunMedSUNMED, LLCBXN2023-08-01
10889483171455SunMedSUNMED, LLCBXN2023-08-01
10889483171462SunMedSUNMED, LLCBXN2023-08-01
10889483171479SunMedSUNMED, LLCBXN2023-08-01
10889483171486SunMedSUNMED, LLCBXN2023-08-01
10889483171844SunMedSUNMED, LLCBXN2023-08-01
06009880396573STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2022-12-08
04048223115794MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2022-11-21
06009880396696STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2022-11-19
16009880396693STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2022-11-19
06009880396689STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2022-11-18
06009880396788Xavant TechnologyXAVANT TECHNOLOGY (PTY) LTDBXN2021-08-18
16009880396785Xavant TechnologyXAVANT TECHNOLOGY (PTY) LTDBXN2021-08-18
04048223115787MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2021-07-13
04048223115770MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2021-07-13