Catalog Number

3323.13

Brand Name

STOMA®

Version/Model Number

3323.13

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

5265f762-169d-46a8-a481-a9968cb357c0

Public Version Date

September 04, 2020

Public Version Number

1

DI Record Publish Date

August 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-