Catalog Number

-

Brand Name

Com-Fit®

Version/Model Number

20342

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

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

-

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

86f5b827-a2f5-4f5a-ad1e-24be774ec168

Public Version Date

May 06, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

D687203422

Quantity per Package

6

Contains DI Package

D687203421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case