Identity
- Trade Name
- IntelliSense Drill Technology FDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- IntelliSense Power Drill 2.0 and Sterilization Tray FDA UDI
- Model / Reference
- IntelliSense Drill 2.0 FDA UDI
- Description
- IntelliSense Power Drill 2.0 and Sterilization Tray FDA UDI
Identifiers
- Catalog Number
- MOI3071005 FDA UDI
- Primary DI / UDI-DI
- B666MOI30710050 FDA UDI
- 510(k) Number
- K143191 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable
IntelliSense Drill Technology by Mcginley Orthopaedic Innovations, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143191 also covers:
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- IntelliSense Drill Technology — MCGINLEY ORTHOPAEDIC INNOVATIONS, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Mcginley Orthopaedic Innovations, Inc
Sources (1)
- FDA UDI 07af836d-f67c-4963-8702-b943824de7a5 36 fields · synced Jun 6, 2026