Catalog Number

416920

Brand Name

SUR-FIT NATURA

Version/Model Number

416920

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

FON

Product Code Name

Bag, Drainage, With Adhesive, Ostomy

Public Device Record Key

d4828ddf-2698-45d0-973c-52c4f0df4f45

Public Version Date

October 31, 2022

Public Version Number

7

DI Record Publish Date

September 01, 2016

Package DI Number

10768455115911

Quantity per Package

3

Contains DI Package

00768455115914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case