Catalog Number

-

Brand Name

INTRAgen

Version/Model Number

INTRAgen

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

-

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

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

73f95257-60c6-4f78-8eb4-d20caee5c121

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 31, 2016

Package DI Number

8800020105035

Quantity per Package

1

Contains DI Package

08800020105011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden crate