Identity
- Trade Name
- VELOCITY ALPHA ™ FDA UDI
- Generic Name
- Multi-purpose surgical power tool system, line-powered FDA UDI
- Model / Reference
- control unit, touchscreen, incl. irrigation pump, 220 V FDA UDI
Identifiers
- Catalog Number
- VAC220 FDA UDI
- Primary DI / UDI-DI
- 04251388956823 FDA UDI
- 510(k) Number
- K191479 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Multi-purpose surgical power tool system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 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
MR Unsafe FDA UDI
Category: Multi-purpose surgical power tool system, line-powered
Velocity Alpha ™ by adeor Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose surgical power tool system, line-powered.
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Cleared under the same submission
K191479 also covers:
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- adeor Medical AG
Sources (1)
- FDA UDI ef2748c8-f0d4-443f-9388-5bd43587886b 34 fields · synced Jun 1, 2026