Catalog Number

16752

Brand Name

TMS Professional Series Level 3 Surgical Face Mask

Version/Model Number

A1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211861,K211861,K211861

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

ff01f603-c0d0-4bb7-adf7-3c3a38f4baf3

Public Version Date

November 12, 2021

Public Version Number

1

DI Record Publish Date

November 04, 2021

Package DI Number

10860007355902

Quantity per Package

40

Contains DI Package

00860007355905

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case