Catalog Number

MCL940L30

Brand Name

MicroFrance®

Version/Model Number

MCL940L30

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

KAC

Product Code Name

TUBE, LARYNGECTOMY

Public Device Record Key

f2c38f7f-77f9-4289-8ac0-8243c290b605

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

January 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-