Catalog Number

409345

Brand Name

ESTEEM SYN POST OP KIT STER

Version/Model Number

409345

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2022

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

7577d1a1-657b-4f8f-84ea-2c5de8b30577

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

10768455105325

Quantity per Package

4

Contains DI Package

00768455105328

Package Discontinue Date

May 20, 2022

Package Status

Not in Commercial Distribution

Package Type

Case