AccessGUDID - DEVICE: NONE (B006IMCF512B0)

GUDID

Device Identifier (DI) Information

Brand Name: NONE
Version or Model: NONE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REUI-MCF512B
Company Name: Neurovision Medical Products, Inc.

Primary DI Number: B006IMCF512B0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
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:	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?
61090	Nerve-locating system probe, reusable	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 reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETN	Stimulator, Nerve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121931	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 323d699b-cd8b-4992-ab30-e2160b468864
Public Version Date: September 09, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016