AccessGUDID - DEVICE: Stimulator Box (09008737370053)

GUDID

Device Identifier (DI) Information

Brand Name: Stimulator Box
Version or Model: 37005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737370053
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Hardware Interface System

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?
63366	Nerve location/function operative test pulse generator	An electrically-powered unit intended to produce electrical signals for preoperative and/or intraoperative application of electrical stimulation, via a connected hand-held probe with distal electrodes (not included), to a neural tissue site to: 1) locate nerves during surgery to prevent unintentional injury; 2) diagnose or assess nerve function; and/or 3) help determine an optimal electrical stimulation site prior to implantation of an active implant [e.g., cochlear implant (CI), auditory brainstem implant (ABI)]. It does not display electromyography (EMG) readings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	127

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9478458e-a344-4743-8fb6-6a43eb340d0e
Public Version Date: November 01, 2024
Public Version Number: 1
DI Record Publish Date: October 24, 2024