Catalog Number

-

Brand Name

Tech Medical Services

Version/Model Number

TMDSIPS533

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103508,K103508

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

12d82962-0790-4668-863d-9935580911fa

Public Version Date

June 28, 2021

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

10851695005422

Quantity per Package

10

Contains DI Package

00851695005425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner