Catalog Number

72-00160-0

Brand Name

N/A

Version/Model Number

7205861

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

K914403,K914403

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

95086dd1-cfc7-4d83-acf5-9be1a3a1862e

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 05, 2021

Package DI Number

10817183020704

Quantity per Package

10

Contains DI Package

00817183020707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK