Catalog Number

010063

Brand Name

Silicone PEG Guidewire System

Version/Model Number

010063

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

290bd0a4-a5d5-413c-aa36-734e763b1ffb

Public Version Date

April 12, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

20801741081235

Quantity per Package

12

Contains DI Package

10801741081238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX