Catalog Number

-

Brand Name

Hollister

Version/Model Number

9778

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

-

Product Code

GDS

Product Code Name

BAG, STOMAL

Public Device Record Key

4b92618b-52e7-4b18-b237-e992f0dd98a4

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

20610075097788

Quantity per Package

16

Contains DI Package

00610075097784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE