dermaPACE System (Console with applicator) - The dermaPACE console and applicator shipped - Sanuwave, Inc.

Duns Number:832217439

Device Description: The dermaPACE console and applicator shipped together. An assembly of devices designed to The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.

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More Product Details

Catalog Number

-

Brand Name

dermaPACE System (Console with applicator)

Version/Model Number

DEP0330/DAP0332

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

-

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

PZL

Product Code Name

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Device Record Status

Public Device Record Key

42a4ff12-ddba-4207-95d6-05cec4725be2

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

January 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SANUWAVE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 7