Catalog Number

-

Brand Name

CATHAY

Version/Model Number

GP202D-T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K130027,K130027,K130027

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

be67cf99-abfb-446c-91e1-bae5a513f3dc

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

June 05, 2019

Package DI Number

16959006300397

Quantity per Package

8

Contains DI Package

06959006300390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case