Catalog Number

-

Brand Name

ENVI

Version/Model Number

48-100

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

be2f9e48-91de-4294-bb9a-82daf483d660

Public Version Date

August 12, 2021

Public Version Number

6

DI Record Publish Date

August 07, 2017

Package DI Number

H965481001

Quantity per Package

10

Contains DI Package

H965481000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX