Catalog Number

-

Brand Name

NA

Version/Model Number

AG-5041-2526

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

7ad856c1-611d-4f11-819f-e406270f7e08

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 09, 2022

Package DI Number

16959664900106

Quantity per Package

10

Contains DI Package

06959664900109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box