Catalog Number

9572C

Brand Name

PROPLATE

Version/Model Number

9572C

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092761,K092761,K092761

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

63fe0483-bd91-44b5-ba41-51457941651e

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

Package DI Number

18809083942882

Quantity per Package

20

Contains DI Package

08809083942885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box