Barco - MDSC-2232 MNA SX - Barco NV

Duns Number:371618773

Device Description: MDSC-2232 MNA SX

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More Product Details

Catalog Number

K9307919

Brand Name

Barco

Version/Model Number

MDSC-2232

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

KQM

Product Code Name

CAMERA, SURGICAL AND ACCESSORIES

Device Record Status

Public Device Record Key

6764ea02-4206-48cf-a387-fb5b58ae29e0

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

July 29, 2020

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