Identity
- Trade Name
- DermaGold100® FDA UDI
- Generic Name
- Dermatological extracorporeal shock wave therapy system FDA UDI
- Device Name
- 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) FDA UDI
- Model / Reference
- OW100-US FDA UDI
- 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) FDA UDI
Identifiers
- Catalog Number
- 1000014 FDA UDI
- Primary DI / UDI-DI
- 04260484571649 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 — 18 Kilogram FDA UDIDepth — 459 Millimeter FDA UDIWidth — 400 Millimeter FDA UDIHeight — 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
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Also classified as Dermatological extracorporeal shock wave therapy system.
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- Dermagold100 — MTS Medical AG · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MTS Medical AG
Sources (1)
- FDA UDI c7484569-df33-43d7-9b5d-3bcc011dd2a4 38 fields · synced May 30, 2026