AccessGUDID - DEVICE: Stimuplex® HNS 12 (04260166372083)

GUDID

Device Identifier (DI) Information

Brand Name: Stimuplex® HNS 12
Version or Model: 4892098
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4892098
Company Name: Stockert GmbH

Primary DI Number: 04260166372083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 327536314 *Terms of Use

Device Description: Stimuplex® HNS 12 Nerv Stimulator with electrode cable / Electrode Cable Ordering-No. 4892070

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:	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?
35723	Nerve-locating system	An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXN	Stimulator, Nerve, Battery-Powered

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
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2673d6f0-632b-4c02-9785-820620353ed8
Public Version Date: April 25, 2018
Public Version Number: 3
DI Record Publish Date: May 04, 2017