Catalog Number

-

Brand Name

Key Surgical Guidewire

Version/Model Number

EN10450B

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

OCY

Product Code Name

Endoscopic Guidewire, Gastroenterology-Urology

Public Device Record Key

bb7ae267-82c1-4520-8fcd-ee6ba18262cf

Public Version Date

September 08, 2021

Public Version Number

3

DI Record Publish Date

March 07, 2020

Package DI Number

00849771039303

Quantity per Package

10

Contains DI Package

00849771039297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box