FDA.reportPublic FDA data

Xavant Technology

Primary DI
06009880396368
Brand
Xavant Technology
Company
XAVANT TECHNOLOGY (PTY) LTD
Model
STIMPOD NMS410 Kit
Catalog number
XT-41011
Device description
The STIMPOD NMS410 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 through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.
Published
2018-11-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K093591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093591000STIMPOD MODEL NMS-400 NERVE STIMULATORXavant Technology (Pty), Ltd.2009-12-03BXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16009880396365PackageGS11Not in Commercial Distribution
26009880396362PackageGS15Not in Commercial Distribution
36009880396369PackageGS12Not in Commercial Distribution
46009880396366PackageGS12Not in Commercial Distribution
56009880396363PackageGS12Not in Commercial Distribution
66009880396360PackageGS13Not in Commercial Distribution
76009880396367PackageGS14Not in Commercial Distribution
06009880396368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1600988039636516009880396365
2600988039636226009880396362
3600988039636936009880396369
4600988039636646009880396366
5600988039636356009880396363
6600988039636066009880396360
7600988039636776009880396367
06009880396368060098803963686009880396368

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009880396139Xavant TechnologySTIMPOD NMS450 KITXT-450112016-12-07
06009880396146Xavant TechnologySTIMPOD NMS450 Kit (3.5m)XT-45011A2017-01-10
06009880396153Xavant TechnologyNMBA Cable with accelerometer (1.5m)XT-450152017-04-06
06009880396313Xavant TechnologySTIMPOD NMS450 KitXT-450212018-01-30
06009880396320Xavant TechnologySTIMPOD NMS450 Kit (3.5m)XT-45021A2018-01-30
06009880396337Xavant TechnologyNMBA Cable with Accelerometer (1.8m)XT-450252018-01-30
06009880396344Xavant TechnologyNMBA Cable with Accelerometer (3.5m)XT-45025A2018-01-30
06009880396788Xavant TechnologySTIMPOD NMS450 AMG Only Kit (1.8m)XT-45021D2021-08-18
06009880396177STIMPODNMT Monitoring Cable EMG (3.0m)XT-45003B2024-11-15
06009880396870STIMPODSTIMPOD NMS450X+XT-450302023-12-23
06009880396030Xavant TechnologyNerve mapping cableXT-460032017-07-18
06009880396078Xavant TechnologySTIMPOD NMS410 KitXT-410012017-06-13
06009880396160Xavant TechnologyNMBA Cable with accelerometer (3.5m)XT-45015A2017-01-10
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

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
06009880396870STIMPODXAVANT 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