Nexxis - MNA-110 ENC HDSDI - Barco NV

Duns Number:371618773

Device Description: MNA-110 ENC HDSDI

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More Product Details

Catalog Number

K9303032A

Brand Name

Nexxis

Version/Model Number

MNA-110

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

DXJ

Product Code Name

DISPLAY, CATHODE-RAY TUBE, MEDICAL

Device Record Status

Public Device Record Key

884da44d-b3b7-4e1e-809b-37b835c3842a

Public Version Date

December 20, 2018

Public Version Number

3

DI Record Publish Date

June 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BARCO NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 105
2 A medical device with a moderate to high risk that requires special controls. 259