NeXus-10 MKII - The NeXus-10 MKII is designed for medical use, - Mind Media B.V.

Duns Number:489837775

Device Description: The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indica

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More Product Details

Catalog Number

-

Brand Name

NeXus-10 MKII

Version/Model Number

1.2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

HCC

Product Code Name

Device, Biofeedback

Device Record Status

Public Device Record Key

6c28a146-c34d-45df-a717-415a08e72c63

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIND MEDIA B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10