AccessGUDID - DEVICE: Neurosign Stimulator Probe Pod (05060229530974)

GUDID

Device Identifier (DI) Information

Brand Name: Neurosign Stimulator Probe Pod
Version or Model: 9967-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THE MAGSTIM COMPANY LIMITED

Primary DI Number: 05060229530974
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 500375274 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46456	Nerve-locating system, line-powered	An assembly of mains electricity (AC-powered) devices designed to locate a nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ETN	Stimulator, Nerve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a306293-2577-455a-a4ca-48a7734f73fe
Public Version Date: December 23, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016