Catalog Number

155-122

Brand Name

STD-ADAPTABLE CLASS III MASK

Version/Model Number

155-122

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

K861424

Product Code

DZB

Product Code Name

Headgear, Extraoral, Orthodontic

Public Device Record Key

57559185-bc45-4d5d-bac0-8c1db061e507

Public Version Date

February 02, 2021

Public Version Number

4

DI Record Publish Date

May 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-