Catalog Number

-

Brand Name

ProGear

Version/Model Number

2300

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

059399fa-509e-42a1-9548-a02e3f278ffd

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 12, 2020

Package DI Number

20852212003621

Quantity per Package

4

Contains DI Package

00852212003627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case