Catalog Number

000792

Brand Name

Ponsky Deluxe PEG Kit

Version/Model Number

000792

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

5dc2bd1c-afdd-4752-856f-1f1bfea3c5d4

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

20801741081136

Quantity per Package

12

Contains DI Package

10801741081139

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX