INTRODUCER SET - VGCTR03 INTRODUCER SET - VALFLUX GROUP, LLC

Duns Number:050193715

Device Description: VGCTR03 INTRODUCER SET

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More Product Details

Catalog Number

VGCTR03

Brand Name

INTRODUCER SET

Version/Model Number

VGCTR03

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

Yes

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

K180178

Product Code Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

1f976e29-6cea-4a5f-a21e-2d15f2e4012b

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

December 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VALFLUX GROUP, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 20