YelloPort Elite - Laparoscopic Port Access System - 12x75 Blunt Trocar - SURGICAL INNOVATIONS LIMITED

Duns Number:771051935

Device Description: 12x75 Blunt Trocar

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More Product Details

Catalog Number

-

Brand Name

YelloPort Elite - Laparoscopic Port Access System

Version/Model Number

ET1207504

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

K190592

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

66c63bc8-93ea-4a06-947c-f276741bdc95

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

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