Catalog Number

000328

Brand Name

PEG Guidewire System

Version/Model Number

000328

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

9abfde25-e770-458e-ae5d-26b535314639

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

10801741086806

Quantity per Package

2

Contains DI Package

00801741086809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA