CLEAR-TRAC - CANNULA THREADED FLEX 5.5 X 55MM - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: CANNULA THREADED FLEX 5.5 X 55MM

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More Product Details

Catalog Number

72200430

Brand Name

CLEAR-TRAC

Version/Model Number

72200430

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"

Yes

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

-

Product Code Details

Product Code

NBH

Product Code Name

ACCESSORIES,ARTHROSCOPIC

Device Record Status

Public Device Record Key

39d1bcf1-0260-44e6-b0c8-c9616e98afe2

Public Version Date

January 31, 2020

Public Version Number

3

DI Record Publish Date

August 29, 2015

Additional Identifiers

Package DI Number

23596010597070

Quantity per Package

10

Contains DI Package

03596010597076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"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