Micromed - The SD LTM STIM is a low power, constant current, - MICROMED SPA

Duns Number:856998166

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

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More Product Details

Catalog Number

-

Brand Name

Micromed

Version/Model Number

SD LTM STIM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180761

Product Code Details

Product Code

GYC

Product Code Name

Electrode, Cortical

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROMED SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12