BRAINSTREAM - CONMED BRAINSTREAM Disposable Deep Cup EEG - Conmed Corporation

Duns Number:071595540

Device Description: CONMED BRAINSTREAM Disposable Deep Cup EEG Electrodes, 150 cm Length, 26 Electrodes

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More Product Details

Catalog Number

72615-M-CM-26

Brand Name

BRAINSTREAM

Version/Model Number

72615-M-CM-26

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

K200540,K200540,K200540

Product Code Details

Product Code

GXY

Product Code Name

Electrode, cutaneous

Device Record Status

Public Device Record Key

4af2f14c-2483-434e-90a0-71a473d8aeb7

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Additional Identifiers

Package DI Number

30653405987103

Quantity per Package

300

Contains DI Package

20653405987106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95