Catalog Number

MCO803

Brand Name

MicroFrance®

Version/Model Number

MCO803

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KAD

Product Code Name

ELEVATOR, ENT

Public Device Record Key

e3d4f30b-7fb5-442c-a3c6-2e5d0d10d982

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

January 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-