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Dermagold100

FDA UDI

Class II (US FDA UDI)

by MTS Medical AG

Identity

Trade Name
Dermagold100 FDA UDI
Generic Name
Dermatological extracorporeal shock wave therapy system FDA UDI
Device Name
The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s). FDA UDI
Model / Reference
OW100S-US FDA UDI
Description
The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s). FDA UDI

Identifiers

Catalog Number
1000022 FDA UDI
Primary DI / UDI-DI
04260484571823 FDA UDI
510(k) Number
K231710 FDA UDI
FDA Product Code
PZL FDA UDI
GMDN Term
Dermatological extracorporeal shock wave therapy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4685 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 21 Kilogram FDA UDI
Depth — 459 Millimeter FDA UDI
Width — 400 Millimeter FDA UDI
Height — 218 Millimeter FDA UDI

Category: Dermatological extracorporeal shock wave therapy system

Dermagold100 by MTS Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatological extracorporeal shock wave therapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MTS Medical AG

Sources (1)

  • FDA UDI 8383f5b2-ee12-4479-841f-69e7c975e7b1 38 fields · synced Jun 8, 2026