FDA.reportPublic FDA data

STIMPOD

Primary DI
06009880396573
Brand
STIMPOD
Company
XAVANT TECHNOLOGY (PTY) LTD
Model
EMG Electrode Large
Catalog number
XT-45009L
Device description
Electrode array to be used with the STIMPOD NMS450 Nerve Stimulator
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
K213049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213049000STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.2022-10-16BXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16009880396570PackageGS110In Commercial Distribution
26009880396577PackageGS115In Commercial Distribution
36009880396574PackageGS120In Commercial Distribution
06009880396573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1600988039657016009880396570
2600988039657726009880396577
3600988039657436009880396574
06009880396573060098803965736009880396573

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.

Regulatory Flags#

DUNS number
639571707
Device count
1
Lot or batch
true
Expiration 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
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
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
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
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