Catalog Number

1154901

Brand Name

PureLife Dental

Version/Model Number

1154901

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

da6e1ff1-848d-47b0-8ace-b26781ecb281

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

August 01, 2020

Package DI Number

D79011549013

Quantity per Package

500

Contains DI Package

D79011549011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case