DermaGold100®

Primary DI
04260484571649
Brand
DermaGold100®
Company
MTS Medical AG
Model
OW100-US
Catalog number
1000014
Device description
The DermaGold100® is intended for treatment of - diabetic footulcers- superficial partial thickness second degree burns in adults (22 years and older). The dermagold100 is indicated for use in conjunction with standard of care burn treatment(s)
Published
2020-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K191961000
K200926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191961000OrthoGoldTissue Regeneration Technologies2019-11-26PZL
K200926000OrthoGold 100Tissue Regeneration Technologies, LLC2020-08-28PZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260484571656PackageGS11In Commercial Distribution
04260484571649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260484571656042604845716564260484571656
04260484571649042604845716494260484571649

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth459Millimeter
Height218Millimeter
Weight18Kilogram
Width400Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure82 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure82 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(404) 402-6844info@trtllc.com

Regulatory Flags#

DUNS number
342585299
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260484571281ChiroGoldOW100S-US10000292025-06-30
04260484571298ChiroGoldOW100S-US10000292025-06-30
04260484571267Softwave Gold LiOW100S-US10000242024-08-30
04260484571274Softwave Gold LiOW100S-US10000242024-08-30
04260484571601OrthoGold100®OW100-US10000132019-01-23
04260484571687VIASUREOW100-US10000152021-07-01
04260484571823Dermagold100OW100S-US10000222023-09-11
04260484573001MTSLG38038000002016-09-24
04260484571625OW100SOW100S-US10000212022-11-29

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
00812265010201dermaPACE ApplicatorSANUWAVE Health, Inc.PZL2021-01-25
00812265010218dermaPACE ConsoleSANUWAVE Health, Inc.PZL2021-01-25
00812265010225dermaPACE System (Console with applicator)SANUWAVE Health, Inc.PZL2021-01-25