Catalog Number

-

Brand Name

Hollister

Version/Model Number

8770

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EXB

Product Code Name

COLLECTOR, OSTOMY

Public Device Record Key

a1bc6c27-1690-4e15-87e8-8dfaf0cac61c

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

January 01, 2018

Package DI Number

20610075087703

Quantity per Package

24

Contains DI Package

00610075087709

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case