Catalog Number

-

Brand Name

Tech Medical Service

Version/Model Number

IN-15-24

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

K111441,K111441

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

1f59e882-24e6-4981-bb45-2c48f451bf8b

Public Version Date

November 18, 2019

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

10851695005644

Quantity per Package

25

Contains DI Package

00851695005647

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner