Catalog Number

-

Brand Name

ENVI

Version/Model Number

35-514

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"

-

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

K170775

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

c6d9f42f-d02e-410c-8ffe-f98b692bf5cc

Public Version Date

August 12, 2021

Public Version Number

6

DI Record Publish Date

August 07, 2017

Package DI Number

H965355141

Quantity per Package

5

Contains DI Package

H965355140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX