Catalog Number

-

Brand Name

CRE Fixed Wire

Version/Model Number

M00558370

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

-

Product Code

KNQ

Product Code Name

Dilator, esophageal

Public Device Record Key

0f7ed5c5-4bf4-47c0-8638-cf653cbef54a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

08714729339304

Quantity per Package

5

Contains DI Package

08714729195993

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-