Catalog Number

006035

Brand Name

Ponsky PEG Safety System

Version/Model Number

006035

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

-

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

ed9224a3-aad8-4179-ba7f-c1e9c3985bb3

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

10801741081184

Quantity per Package

18

Contains DI Package

00801741081187

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX