Catalog Number

TC-200

Brand Name

Key Surgical Cautery Tip Cleaner

Version/Model Number

TC-200

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

K151222,K151222

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

8d230e0e-bf82-4b13-97b7-d22fe7e4cd62

Public Version Date

September 08, 2021

Public Version Number

6

DI Record Publish Date

August 23, 2016

Package DI Number

10849771030499

Quantity per Package

100

Contains DI Package

00849771030492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case