DYONICS - DYONICS PULSE SOFTWARE TOP LEVEL - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: DYONICS PULSE SOFTWARE TOP LEVEL

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More Product Details

Catalog Number

72204606

Brand Name

DYONICS

Version/Model Number

72204606

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OUG

Product Code Name

Medical device data system

Device Record Status

Public Device Record Key

92b0cd5b-9309-4cc0-b315-ad15e5a18ea8

Public Version Date

March 18, 2022

Public Version Number

4

DI Record Publish Date

April 12, 2016

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