Clinical review 2MP - Barco NV

Duns Number:371618773

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More Product Details

Catalog Number

-

Brand Name

Clinical review 2MP

Version/Model Number

MDRC-2224 WP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 19, 2016

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

LMD

Product Code Name

System, digital image communications, radiological

Device Record Status

Public Device Record Key

e50a7f79-7d05-4114-ac83-637d23bae956

Public Version Date

October 24, 2022

Public Version Number

4

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