TRIVEX - MTO TRIVEX TM ITALIAN KIT 230-240V - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: MTO TRIVEX TM ITALIAN KIT 230-240V

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More Product Details

Catalog Number

7205944

Brand Name

TRIVEX

Version/Model Number

7205944

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 02, 2020

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

94e91041-bec1-417c-b474-e60565717b7c

Public Version Date

July 06, 2020

Public Version Number

3

DI Record Publish Date

August 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351