CO2 Hose and DIN - CO2 Hose and DIN for use with Laparoscopic - NORTHGATE TECHNOLOGIES INC.

Duns Number:627969264

Device Description: CO2 Hose and DIN for use with Laparoscopic insufflators

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More Product Details

Catalog Number

-

Brand Name

CO2 Hose and DIN

Version/Model Number

7-510-36

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K022052

Product Code Details

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Device Record Status

Public Device Record Key

5f898022-881d-40e9-ad6f-129b213db4ad

Public Version Date

July 04, 2022

Public Version Number

4

DI Record Publish Date

October 14, 2016

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