CERVELLO 64 W - Cervello 64 LTM / Ambulatory Headbox, needs Jack - BLACKROCK NEUROMED, LLC

Duns Number:069799474

Device Description: Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - WiFi Model

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More Product Details

Catalog Number

NM-0262

Brand Name

CERVELLO 64 W

Version/Model Number

NM-0262

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

-

Product Code Details

Product Code

GWK

Product Code Name

Conditioner, Signal, Physiological

Device Record Status

Public Device Record Key

9fdb6c2e-14d5-4815-b960-c089919e8ab8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 06, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLACKROCK NEUROMED, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9