Catalog Number

507952

Brand Name

PILLING

Version/Model Number

IPN916176

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

18063be0-87b0-4678-9524-56c3ff16809a

Public Version Date

March 19, 2021

Public Version Number

1

DI Record Publish Date

March 11, 2021

Package DI Number

24026704719901

Quantity per Package

10

Contains DI Package

14026704719904

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box