dermaPACE Console

Primary DI
00812265010218
Brand
dermaPACE Console
Company
SANUWAVE Health, Inc.
Model
DEP0330
Device description
Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock Waves (ESW) for the treatment of Diabetic Foot Ulcers.
Published
2021-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot UlcersGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160037000dermaPACE SystemSanuwave, Inc.2017-12-28PZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812265010218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812265010218008122650102188122650102180812265010218

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological extracorporeal shock wave therapy systemAn 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 focused by an internal reflector and delivered non-invasively to the area of the skin in contact with the applicator. Treatment parameters are intended to be input manually by a healthcare professional.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
678-578-0108oder@sanuwave.com

Regulatory Flags#

DUNS number
962510686
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812265010201dermaPACE ApplicatorDAP03322021-01-25
00812265010225dermaPACE System (Console with applicator)DEP0330/DAP03322021-01-25
00812265010287Profile ConsolePRF1002021-01-25
00812265010294Profile Applicator FLE01032021-01-25
00812265010300Profile Applicator FLE01042021-01-25
00812265010317UltraMIST GeneratorCP-800312021-01-25
00812265010324UltraMIST Treatment WandCP-800332021-01-25
00812265010331UltraMIST Single Use ApplicatorAS-550572021-01-25
00812265010348UltraMIST Single Use Applicator (12 Pack)CP-800402021-01-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04260484571274Softwave Gold LiMTS Medical AGPZL2024-08-30
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04260484571830Dermagold100MTS Medical UG (haftungsbeschränkt)PZL2023-09-11
07630039101404DUOLITH®Storz Medical AGPZL2021-06-29
07630039101398DUOLITH®Storz Medical AGPZL2021-04-08
00812265010201dermaPACE ApplicatorSANUWAVE Health, Inc.PZL2021-01-25
00812265010225dermaPACE System (Console with applicator)SANUWAVE Health, Inc.PZL2021-01-25
04260484571649DermaGold100®MTS Medical AGPZL2020-03-31