Catalog Number

PG-MHL1

Brand Name

Hope

Version/Model Number

PG-MHL1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K023755,K023755,K023755

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

8d5ffdc8-d5f4-41c2-9a8e-798b762c1553

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

July 02, 2021

Package DI Number

D066PGMHL12

Quantity per Package

40

Contains DI Package

D066PGMHL11

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-