Identity
- Trade Name
- XCELLARISPRO TWIST Control unit FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- The control unit is one component of the XCELLARISPRO TWIS microneedling system. FDA UDI
- Model / Reference
- VK-2000.010.01 FDA UDI
- Description
- The control unit is one component of the XCELLARISPRO TWIS microneedling system. FDA UDI
Identifiers
- Catalog Number
- VK-2000.010.01 FDA UDI
- Primary DI / UDI-DI
- 04260446131072 FDA UDI
- 510(k) Number
- K241790 FDA UDI
- FDA Product Code
- QAI FDA UDI
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4430 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
Category: Surgical power tool system control unit, line-powered
XCELLARISPRO TWIST Control unit by Dermaroller GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Dermaroller GmbH
Sources (1)
- FDA UDI cd229551-4033-4c1c-baca-aaebdd730d5e 35 fields · synced May 30, 2026