FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal Chuck Set for the IntelliSense Drill System
DI: B666MOI30700090
·
Model: 1.0
·
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Universal Chuck Set for the IntelliSense Drill System
- Primary DI
- B666MOI30700090
- Version / Model
- 1.0
- Catalog Number
- MOI3070009
- Company Name
- MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
- Labeler DUNS
- 078568266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-30
- Public Version
- 1
- Public Version Date
- 2025-06-09
- Public Version Status
- New
- Public Device Record Key
- 0d4bfced-aa68-44b0-88fc-ad3de46b7db2
Device Description
Universal Chuck Set for the IntelliSense Drill System in Sterilization Tray
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31048 | Surgical drill chuck | A device designed to grip a cutting tool (normally a drill bit or other rotational cutting tool) using three adjustable jaws that are geared to be manually closed concentrically upon the cutting tool. It is attached (locked) to a surgical drilling machine which is usually powered, but may be manual. A special key is often used to close and tighten the jaws. Commonly known as a Jacobs chuck, it is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B666MOI30700090 | HIBCC |
Customer Contacts
- Phone
- 3073156403
- [email protected]