Catalog Number

PMKBAND-L

Brand Name

Focus Knee Replacement Band - Large

Version/Model Number

PMKBAND-L

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

-

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

K183215,K183215,K183215

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

398f074f-6e50-481c-8516-629525513874

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 15, 2020

Package DI Number

20073796124421

Quantity per Package

5

Contains DI Package

10073796124424

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case