Catalog Number

-

Brand Name

ENVI

Version/Model Number

35-502

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 03, 2019

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

e6c7d657-8271-4df3-88f8-557a7fe988bc

Public Version Date

August 12, 2021

Public Version Number

7

DI Record Publish Date

August 07, 2017

Package DI Number

H965355021

Quantity per Package

5

Contains DI Package

H965355020

Package Discontinue Date

June 03, 2019

Package Status

Not in Commercial Distribution

Package Type

BOX