FDA UDI
In Commercial Distribution
🇺🇸 United States
VELOCITY ALPHA ™
DI: 04251388956854
·
Model: foot control, electric, Bluetooth™ wireless, incl. Bluetooth™ dongle VAFCD
·
adeor Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VELOCITY ALPHA ™
- Primary DI
- 04251388956854
- Version / Model
- foot control, electric, Bluetooth™ wireless, incl. Bluetooth™ dongle VAFCD
- Catalog Number
- VAFCBT
- Company Name
- adeor Medical AG
- Labeler DUNS
- 341188943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-06
- Public Version
- 2
- Public Version Date
- 2024-09-19
- Public Version Status
- Update
- Public Device Record Key
- 78b46628-c323-4c53-af4b-f74d1eddb4c7
Device Description
foot control, electric, Bluetooth™ wireless, incl. Bluetooth™ dongle VAFCD and bar for foot switch VMME-FS-H
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | 882.4310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66243 | Bone/joint surgical power tool motorized handpiece/set, electric, reusable | An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251388956854 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191479 | 000 |