Catalog Number

H965180011

Brand Name

Wallstent

Version/Model Number

H965180011

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

0aea76a1-ab4d-4784-a13e-836ad1516cc1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 06, 2016

Package DI Number

08714729203063

Quantity per Package

5

Contains DI Package

08714729203070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-