Xavant Technology

Basic Information

• Brand Name: Xavant Technology
• Primary DI: 06009880396146
• Version / Model: STIMPOD NMS450 Kit (3.5m)
• Catalog Number: XT-45011A
• Company Name: XAVANT TECHNOLOGY (PTY) LTD
• Labeler DUNS: 639571707
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 03ba9f6e-91e1-4757-8db0-28d47079ec10

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	868.2775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35729	Diagnostic peripheral nerve electrical stimulation system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	46009880396144	GS1	Box	2	In Commercial Distribution
Package	36009880396147	GS1	Box	2	In Commercial Distribution
Package	26009880396140	GS1	Box	5	In Commercial Distribution
Primary	06009880396146	GS1
Package	16009880396143	GS1	Box	1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K102084	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius