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XAVANT TECHNOLOGY (PTY) LTD · Model STIMPOD NMS450 Kit (3.5m) · UDI-DI 06009880396146

BXN Prescription
1
510(k) clearances
31
Adverse events
5
Recalls
19
Facilities

Description

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.

Recalls

DateFirmReason
2024-05-17B Braun Medical IncThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17B Braun Medical IncThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17B Braun Medical IncThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17B Braun Medical IncThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2010-02-01Stryker Instruments Div. of Stryker CorporationDevice may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.