Catalog Number

700-118

Brand Name

Sage Fecal Management System

Version/Model Number

700-118

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

EXB

Product Code Name

COLLECTOR, OSTOMY

Public Device Record Key

c66e24db-dbbc-4212-97f9-3b7213ee3c09

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

50618029980057

Quantity per Package

10

Contains DI Package

00618029980052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case