VersaOne - Fascial Closure System Optical Trocar with - Covidien LP

Duns Number:058614483

Device Description: Fascial Closure System Optical Trocar with Fixation Cannula, Standard

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More Product Details

Catalog Number

-

Brand Name

VersaOne

Version/Model Number

ONB12STFCS

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

Yes

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

K163654,K163654

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

ef730859-5018-4269-83a5-3c0ef0e46987

Public Version Date

August 24, 2022

Public Version Number

4

DI Record Publish Date

August 25, 2018

Additional Identifiers

Package DI Number

20884521678719

Quantity per Package

6

Contains DI Package

10884521678712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40