dermaPACE Applicator

Primary DI
00812265010201
Brand
dermaPACE Applicator
Company
SANUWAVE Health, Inc.
Model
DAP0332
Device description
Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers
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
00812265010201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812265010201008122650102018122650102010812265010201

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological extracorporeal shock wave therapy system applicatorA hand-held component of a dermatological extracorporeal shock wave therapy (ESWT) system designed to transmit spark-gap-generated (electrohydraulic) shock waves to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; traumatic wounds; cellulite). It is connected to the system generator by a flexible conduit and has a fluid-filled head portion intended to be moved over the skin surface of the treatment area for application of the shock waves. It is typically used with a sterile drape during treatment of open wounds and requires a sterile transmission media (ultrasonic gel). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812265010218dermaPACE ConsoleDEP03302021-01-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014430503CS-Pro MEDCURATIVE SOUND, LLCPZL2026-01-02
04260484571267Softwave Gold LiMTS Medical AGPZL2024-08-30
04260484571274Softwave Gold LiMTS Medical AGPZL2024-08-30
04260484571823Dermagold100MTS Medical AGPZL2023-09-11
04260484571830Dermagold100MTS Medical UG (haftungsbeschränkt)PZL2023-09-11
07630039101404DUOLITH®Storz Medical AGPZL2021-06-29
07630039101398DUOLITH®Storz Medical AGPZL2021-04-08
00812265010218dermaPACE ConsoleSANUWAVE Health, Inc.PZL2021-01-25
00812265010225dermaPACE System (Console with applicator)SANUWAVE Health, Inc.PZL2021-01-25
04260484571649DermaGold100®MTS Medical AGPZL2020-03-31