Catalog Number

-

Brand Name

ProGear

Version/Model Number

RP88021

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

MSH

Product Code Name

Respirator, Surgical

Public Device Record Key

9e4af25a-6b90-437c-b38e-cb4dfc1c7459

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Package DI Number

10852212003686

Quantity per Package

6

Contains DI Package

00852212003689

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-