VersaOne - Bladed Trocar with Smooth Cannula - Covidien LP

Duns Number:058614483

Device Description: Bladed Trocar with Smooth Cannula

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More Product Details

Catalog Number

B12STS

Brand Name

VersaOne

Version/Model Number

B12STS

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

K151548,K151548

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

34e132d5-53b5-4dd9-8bf0-66ccda33f286

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 22, 2017

Additional Identifiers

Package DI Number

20884521539881

Quantity per Package

6

Contains DI Package

10884521539884

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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