Catalog Number

E3645

Brand Name

OptiMumm

Version/Model Number

E3645

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

K980915,K980915

Product Code

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Public Device Record Key

8530cbf1-9c36-479e-abcc-84c524d8d584

Public Version Date

August 17, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884524000319

Quantity per Package

10

Contains DI Package

10884524000312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE