Catalog Number

CF-5442/C

Brand Name

Flex-Neck®

Version/Model Number

00884450330180

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

bdc4a21c-953a-4406-b151-15d6b1d9d430

Public Version Date

October 11, 2021

Public Version Number

6

DI Record Publish Date

February 09, 2018

Package DI Number

10884450330187

Quantity per Package

30

Contains DI Package

00884450330180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-