N/A - CO2 Hose and Yoke, Insufflation - NORTHGATE TECHNOLOGIES INC.

Duns Number:627969264

Device Description: CO2 Hose and Yoke, Insufflation

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More Product Details

Catalog Number

72-00146-0

Brand Name

N/A

Version/Model Number

4270

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Device Record Status

Public Device Record Key

e5f2f396-3cee-4ed8-8759-dc5446344e46

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

January 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORTHGATE TECHNOLOGIES INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 54