DYONICS 25 - KIT DYONICS 25 GERMAN - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: KIT DYONICS 25 GERMAN

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More Product Details

Catalog Number

72200214

Brand Name

DYONICS 25

Version/Model Number

72200214

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 03, 2017

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

HRX

Product Code Name

ARTHROSCOPE

Device Record Status

Public Device Record Key

a5c2a8e0-6824-4e5f-9ef2-2d97b2b15337

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 29, 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