XAVANT TECHNOLOGY (PTY) LTD

Address:Unit 102 The Tannery Industrial Park,Pretoria Gauteng,ZA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Nerve, Battery-Powered (BXN) (5)

Premarket Exempt

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Xavant Technology - 06009880396320 Catalog Number : XT-45021A

Device Description : The STIMPOD NMS 450 is a precision nerve locating tool used for localizing speci The STIMPOD NMS 450 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. The STIMPOD (NMS 450) includes Neuromuscular Blocking Agent Monitoring functionality with real-time feedback achieved by tri-axial accelerometry.

Device Class :

Duns Number: 639571707

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

Xavant Technology - 06009880396337 Catalog Number : XT45025

Device Description : Neuromuscular blocking agent monitoring cable (1.8 m) with three dimensional acc Neuromuscular blocking agent monitoring cable (1.8 m) with three dimensional acceleromyography.

Device Class :

Duns Number: 639571707

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

Xavant Technology - 06009880396344 Catalog Number : XT-45025A

Device Description : Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acc Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.

Device Class :

Duns Number: 639571707

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

Xavant Technology - 06009880396368 Catalog Number : XT-41011

Device Description : The STIMPOD NMS410 is a precision nerve locating tool used for localizing specif 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.

Device Class :

Duns Number: 639571707

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

Xavant Technology - 06009880396788 Catalog Number : XT-45021D

Device Description : Quantitative NMT Monitor

Device Class :

Duns Number: 639571707

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

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