Catalog Number

Sil.Flex Stoma Pad #2

Brand Name

galemed

Version/Model Number

SP02

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

-

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

CBH

Product Code Name

Device, Fixation, Tracheal Tube

Public Device Record Key

1cbb7fd2-e418-48c9-b9d0-2091cec842b1

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

64710810116461

Quantity per Package

16

Contains DI Package

24710810116463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton