Catalog Number

-

Brand Name

ProGear

Version/Model Number

FM81020

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"

-

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

f3236011-509b-445f-be50-2974d344071e

Public Version Date

May 06, 2020

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

20852212003096

Quantity per Package

10

Contains DI Package

00852212003092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case