FDA.reportPublic FDA data

BIONESS

Primary DI
06009880396184
Brand
BIONESS
Company
XAVANT TECHNOLOGY (PTY) LTD
Model
STIMPOD ST2-3000 KIT
Catalog number
ST2-3000
Device description
The STIMPOD ST2-3000 is a nerve stimulation device designed to be used for the purpose of nerve locating using percutaneous electrodes or needles (not supplied).
Published
2025-02-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140853000STIMPOD ST2-3010 NERVE STIMULATORXavant Technology (Pty), Ltd.2014-11-06BXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009880396184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009880396184060098803961846009880396184

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic peripheral nerve electrical stimulation systemAn assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
639571707
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009880396085Xavant TechnologyNerve Locate CableXT-410032017-01-25
06009880396245Xavant TechnologySTIMPOD NMS460 KITXT-460012017-03-23
06009880396825Xavant TechnologySTIMPOD NMS460XT-46000A2023-11-11
06009880396832Xavant TechnologySTIMPOD NMS460 KitXT-46001A2023-06-02
06009880396443BIOVENTUSSTIMPOD ST2-4010ST2-40102025-07-30
06009880396610STIMPOD X-LINKXT-45300XT-453002025-07-30
06009880396191BIONESSSTIMPOD ST2-3100 Stimulation Adapter CableST2-31002025-02-17
06009880396177STIMPODNMT Monitoring Cable EMG (3.0m)XT-45003B2024-11-15
06009880396429STIMPODNMT Monitoring Cable AMG (3.0m)XT-45025B2024-11-15
06009880396870Xavant TechnologySTIMPOD NMS450 KitXT-450302023-12-23
06009880396573STIMPODEMG Electrode LargeXT-45009L2022-12-08
06009880396696STIMPODNMT Monitoring Cable EMG (3.5m)XT45003A2022-11-19
06009880396689STIMPODNMT Monitoring Cable EMG (1.8m)XT450032022-11-18
16009880396693STIMPODNMT Monitoring Cable EMG (3.5m)XT45003A2022-11-19
06009880396788Xavant TechnologySTIMPOD NMS450 AMG Only Kit (1.8m)XT-45021D2021-08-18
16009880396785Xavant TechnologySTIMPOD NMS450 AMG Only Kit (1.8m)XT-45021D2021-08-18
06009880396030Xavant TechnologyNerve mapping cableXT-460032017-07-18
46009880396243Xavant TechnologySTIMPOD NMS460 KITXT-460012017-03-23
06009880396368Xavant TechnologySTIMPOD NMS410 KitXT-410112018-11-02
76009880396367Xavant TechnologySTIMPOD NMS410 KitXT-410112018-11-02

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
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
04048223075920MULTISTIM SENSORPajunk GmbH MedizintechnologieBXN2021-04-02