Identity
- Trade Name
- VELOCITY ALPHA ™ FDA UDI
- Generic Name
- Multi-purpose surgical power tool system, line-powered FDA UDI
- Model / Reference
- angled nosepiece XL FDA UDI
Identifiers
- Catalog Number
- VMN-A4 FDA UDI
- Primary DI / UDI-DI
- 04251388939376 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
Moist Heat or Steam Sterilization 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.
- DYONICS POWER — Smith & Nephew, Inc. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- UNIDRIVE — Karl Storz GmbH & Co. KG · Class II
- ROTOCUT — Karl Storz GmbH & Co. KG · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- REAL INTELLIGENCE — Smith & Nephew, Inc. · Class II
- Endo Motor — DENJOY DENTAL CO., LTD · Class I
- Endo Motor — DENJOY DENTAL CO., LTD · Class I
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 249e5a03-9ccf-4bb8-b5ba-9945d184e5ae 34 fields · synced Jun 1, 2026