FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal Chuck Set for the IntelliSense Drill System
DI: B666MCG80070
·
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
- B666MCG80070
- Version / Model
- 1.0
- Catalog Number
- MCG8007
- Company Name
- MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
- Labeler DUNS
- 078568266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 1
- Public Version Date
- 2022-12-13
- Public Version Status
- New
- Public Device Record Key
- c94d7f15-712c-482e-87ee-20d4c410f6aa
Device Description
Universal Key to the keyed chuck for IntelliSense Drill
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 |
|---|---|---|---|---|
| 44605 | Surgical drill chuck key | A hand-held device designed to close and tighten the adjustable jaws of a surgical drill chuck onto a cutting tool, normally a drill bit or other rotational cutting tool, for a firm grip. It is inserted into any one of three side holes that are spaced around the inner barrel of the chuck, and will engage the geared portion of the outer barrel. When rotated, the key will turn the outer barrel, which in turn closes and locks the jaws of the chuck upon the cutting tool. To loosen, the reverse action is taken. 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 | B666MCG80070 | HIBCC |
Customer Contacts
- Phone
- 3073156403
- [email protected]