AccessGUDID - DEVICE: dermaPACE System (Console with applicator) (00812265010225)

GUDID

Device Identifier (DI) Information

Brand Name: dermaPACE System (Console with applicator)
Version or Model: DEP0330/DAP0332
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sanuwave, Inc.

Primary DI Number: 00812265010225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832217439 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59043	Dermatological extracorporeal shock wave therapy system	An assembly of devices designed to provide spark-gap-generated extracorporeal shock wave therapy (ESWT) intended to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; postoperative or traumatic wounds; cellulite). It typically consists of a generator that supplies the high voltage energy; and a hand-held, fluid-filled, shock wave applicator that produces spark-gap (electrohydraulic) energy delivered non-invasively to the area of the skin in contact with the applicator. Treatment parameters are intended to be input manually or from a pre-programmed radio-frequency identification (RFID) card.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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