YelloPort.tif - LAPAROSCOPIC PORT ACCESS SYSTEMStopcock Tap - SURGICAL INNOVATIONS LIMITED

Duns Number:771051935

Device Description: LAPAROSCOPIC PORT ACCESS SYSTEMStopcock Tap AssemblyLaparoscopic sleeve -

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More Product Details

Catalog Number

-

Brand Name

YelloPort.tif

Version/Model Number

Stopcock Tap Assembly

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

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)

-

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

026a59f9-5990-4fda-8637-1521a7674935

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

December 08, 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