Identity
- Trade Name
- Vilex Drill FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use, non-sterile FDA UDI
- Device Name
- Drill, 3.5mm Solid QC, 195/50mm flute (AVID) FDA UDI
- Model / Reference
- DA3550 FDA UDI
- Description
- Drill, 3.5mm Solid QC, 195/50mm flute (AVID) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731119650 FDA UDI
- 510(k) Number
- K041287 FDA UDI
- FDA Product Code
- HRS FDA UDIHTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fluted surgical drill bit, single-use, non-sterile
Vilex Drill by Vilex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, single-use, non-sterile.
- Simpex Drill Bit — SIMPEX MEDICAL, INC. · Class I
- Dynamic Axial Fixator — Orthofix, Inc. · Class II
- Dynamic Axial Fixator — Orthofix, Inc. · Class II
- CURE ACP — MEDITECH SPINE, LLC · Class II
- Simpex Drill Bit — SIMPEX MEDICAL, INC. · Class I
- XtraFix® — Zimmer, Inc. · Class I
- CALIBRATED DRILL BIT — Biomet Orthopedics, Inc. · Class I
- AFT™ Proximal Humerus Fracture Plate System — Shoulder Options, Inc. · Class II
Cleared under the same submission
K041287 also covers:
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
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
- Vilex, Inc.
Sources (1)
- FDA UDI ccabafad-4bb0-4f5b-8bef-c6b90cd49b31 34 fields · synced May 30, 2026