Catalog Number

-

Brand Name

Omeza®

Version/Model Number

CM-720.001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211972,K211972

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

fe254fa2-1cd7-437e-9b86-b699382143c2

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Package DI Number

00859839007212

Quantity per Package

10

Contains DI Package

00859839007014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box CM-720.010