AccessGUDID - DEVICE: Micromed (08033928120828)

GUDID

Device Identifier (DI) Information

Brand Name: Micromed
Version or Model: SD LTM STIM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICROMED SPA

Primary DI Number: 08033928120828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 856998166 *Terms of Use

Device Description: The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).

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?
35726	Somatosensory electrical stimulation system	An assembly of devices used to apply precisely timed and repeatable electrical stimuli to the peripheral nerves, typically for evoked potential and other research procedures (e.g., functional mapping in epilepsy). It is usually a multichannel external stimulation system, consisting of external surface electrodes or invasive (i.e., needle) electrodes, and a pulse generator. It may be used as a component of more complex devices such as somatosensory evoked-potential recording systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYC	Electrode, Cortical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180761	000

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: e66b9144-97bc-433f-b1d8-df8cd84a53c3
Public Version Date: August 02, 2018
Public Version Number: 1
DI Record Publish Date: July 02, 2018