Catalog Number

450-10001

Brand Name

Health-Tec EarLoop Masks, Sensitive

Version/Model Number

450-10001

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"

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

3cf5ae78-3587-4836-bd09-d58fe769c92f

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

January 24, 2017

Package DI Number

D773450100013

Quantity per Package

10

Contains DI Package

D773450100011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-