YelloPort Plus - Laparoscopic Port Access System - 12x150 Cannula + Angle + Stopcock - SURGICAL INNOVATIONS LIMITED

Duns Number:771051935

Device Description: 12x150 Cannula + Angle + Stopcock

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More Product Details

Catalog Number

-

Brand Name

YelloPort Plus - Laparoscopic Port Access System

Version/Model Number

YC1215022

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 14, 2022

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

K070712

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

021d0e38-54fa-4a62-bd36-19a5e6a6670c

Public Version Date

April 15, 2022

Public Version Number

5

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURGICAL INNOVATIONS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 335