AccessGUDID - DEVICE: Neurosign Disposable XL Pedicle Screw Probe (05060229531377)

GUDID

Device Identifier (DI) Information

Brand Name: Neurosign Disposable XL Pedicle Screw Probe
Version or Model: 4056-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: THE MAGSTIM COMPANY LIMITED

Primary DI Number: 05060229531377
Issuing Agency: GS1
Commercial Distribution End Date: February 25, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 500375274 *Terms of Use

Device Description: 3mm Ball; 200mm x 1mm electrode 1.9m wire with DIN42802 connector

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:	Yes
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?
61089	Nerve-locating system probe, single-use	A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXZ	Electrode, Needle

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8fb5925-bbe5-42f9-ab49-5f6b70f3342f
Public Version Date: September 20, 2021
Public Version Number: 4
DI Record Publish Date: September 23, 2016