AccessGUDID - DEVICE: Montgomery® Nerve Stimulator Accessories (EBESMNS6601)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Nerve Stimulator Accessories
Version or Model: MNS660
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MNS660
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBESMNS6601
Issuing Agency: HIBCC
Commercial Distribution End Date: February 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: NS1000 Probe Tip

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?
37246	Patient monitoring system module, nerve location	A small unit dedicated to the localization of a nerve in an area of the body. It is used, e.g., in the administration of relaxants and local anaesthesia and is comprised of a nerve stimulator and a receiver which registers the activity signal of nerves. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the parameters/information measured and provided by this module.	Active	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: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7869577-6e62-4be9-8b4c-6be0dbbdfa5f
Public Version Date: August 30, 2022
Public Version Number: 3
DI Record Publish Date: September 20, 2015