MediCap - MVR400Z - MEDICAPTURE, INC.

Duns Number:788868904

Device Description: MVR400Z

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More Product Details

Catalog Number

-

Brand Name

MediCap

Version/Model Number

MVR400Z

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)

-

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

2d059a75-33a6-4da5-aaa8-a0c1eb2da454

Public Version Date

May 19, 2020

Public Version Number

2

DI Record Publish Date

February 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAPTURE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7