FDA.reportPublic FDA data

BIOVENTUS

Primary DI
06009880396443
Brand
BIOVENTUS
Company
XAVANT TECHNOLOGY (PTY) LTD
Model
STIMPOD ST2-4010
Catalog number
ST2-4010
Device description
The STIMPOD ST2-4010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-4010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle.
Published
2025-07-30
Public version status
New
Distribution status
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
06009880396443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009880396443060098803964436009880396443

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

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
06009880396184BIONESSSTIMPOD ST2-3000 KITST2-30002025-02-17
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
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
04048223075920MULTISTIM SENSORPajunk GmbH MedizintechnologieBXN2021-04-02