Catalog Number

-

Brand Name

ProGear

Version/Model Number

FM89011

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

aba68189-7b44-44e1-8ad3-ec10f3649adb

Public Version Date

April 06, 2020

Public Version Number

2

DI Record Publish Date

September 17, 2019

Package DI Number

10852212003501

Quantity per Package

4

Contains DI Package

00852212003504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case