Catalog Number

-

Brand Name

Infyna Chic

Version/Model Number

8112

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

K213575,K213575,K213575

Product Code

EZD

Product Code Name

CATHETER, STRAIGHT

Public Device Record Key

66856fdf-349b-48a6-8dbf-d646a0512af6

Public Version Date

October 03, 2022

Public Version Number

4

DI Record Publish Date

February 01, 2021

Package DI Number

10610075072665

Quantity per Package

8

Contains DI Package

00610075072668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case