Catalog Number

450-8000B2

Brand Name

Health-Tec Ultra Earloop Masks

Version/Model Number

450-8000B2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2019

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

519dc9bf-e98b-4c4f-8cf4-ca17e490b49e

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

January 24, 2017

Package DI Number

D7734508000B22

Quantity per Package

10

Contains DI Package

D7734508000B21

Package Discontinue Date

October 31, 2019

Package Status

Not in Commercial Distribution

Package Type

-