Catalog Number

-

Brand Name

The OR Company-InsufflatOR Needle

Version/Model Number

IN-12-4

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

-

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

c333cf6d-6cf2-45da-bc96-609327781cf5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

04711605991667

Quantity per Package

20

Contains DI Package

04711605991650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton