CORTAC - SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, - PMT CORPORATION

Duns Number:039576871

Device Description: SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 4X4, TEXTURED, INLINE CONNECTOR, 1 TOP EXIT SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 4X4, TEXTURED, INLINE CONNECTOR, 1 TOP EXIT, TOP & BOTTOM ROWS NUMBERED

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More Product Details

Catalog Number

-

Brand Name

CORTAC

Version/Model Number

2110TX-16-073

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

Yes

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

K082474

Product Code Details

Product Code

GYC

Product Code Name

Electrode, Cortical

Device Record Status

Public Device Record Key

97af1129-a7fb-480a-9e96-2c0931d932fd

Public Version Date

July 06, 2021

Public Version Number

1

DI Record Publish Date

June 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PMT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 673
2 A medical device with a moderate to high risk that requires special controls. 8273
U Unclassified 1188