Catalog Number

-

Brand Name

INTRAgen Tip

Version/Model Number

KT-07

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

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

K142833,K142833,K142833

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

ebec6460-460c-4e45-96ad-2760686d4316

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 31, 2016

Package DI Number

28800020105022

Quantity per Package

5

Contains DI Package

18800020105025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Big box