Catalog Number

612845

Brand Name

D'VILL™

Version/Model Number

612845

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

K171206

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

3a0f6b22-7429-48c6-b622-fad991f33de3

Public Version Date

March 25, 2020

Public Version Number

4

DI Record Publish Date

March 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-