Catalog Number

507604

Brand Name

Pilling

Version/Model Number

IPN008022

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

-

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

FAT

Product Code Name

Bougie, esophageal, and gastrointestinal, gastro-urology

Public Device Record Key

8a8372f2-cf18-4ead-82e4-b458235792e0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

44026704417122

Quantity per Package

20

Contains DI Package

24026704417128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box