Catalog Number

507615

Brand Name

PILLING

Version/Model Number

IPN008033

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

92acbf84-f63d-40c6-bec7-f46afabc8a60

Public Version Date

November 06, 2020

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

44026704417238

Quantity per Package

10

Contains DI Package

24026704417234

Package Discontinue Date

June 26, 2020

Package Status

Not in Commercial Distribution

Package Type

Brick