DyeVert - DYEVERT™ CONTRAST MODULATION SYSTEM - OSPREY MEDICAL INC.

Duns Number:938215568

Device Description: DYEVERT™ CONTRAST MODULATION SYSTEM

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

DyeVert

Version/Model Number

AA-HV

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2018

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

Yes

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

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

cd2db9cd-eea0-40ff-9059-7c63e3e9eba3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSPREY MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21