Catalog Number

-

Brand Name

Hollister

Version/Model Number

9782

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K932855,K932855,K932855

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

e51a4f27-9d5e-4723-8b35-b3cad97007d6

Public Version Date

August 08, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

20610075097825

Quantity per Package

24

Contains DI Package

00610075097821

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case