AccessGUDID - DEVICE: NONE (B006PSS13DF52)

GUDID

Device Identifier (DI) Information

Brand Name: NONE
Version or Model: NONE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DSPPSS13DF-5
Company Name: Neurovision Medical Products, Inc.

Primary DI Number: B006PSS13DF52
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 182057401 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	Active	false
61088	Aspiration nerve-locating system probe	A sterile, hand-held surgical instrument intended to apply a controlled electrical stimulus to a specific body site to locate nerves during surgery and for diagnostic purposes [electromyography (EMG)], as well as to provide a dry surgical field via suction cannula. It is typically used in open surgical procedures and is intended to be connected to an appropriate EMG pulse generating and recording device and a source of suction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKT	Electrode, Needle, Diagnostic Electromyograph
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: Yes
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: 344e7d5e-2432-4f83-9fec-28f66f7504ce
Public Version Date: September 04, 2025
Public Version Number: 9
DI Record Publish Date: September 24, 2016