FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelliSense Drill Technology
DI: B666MCG160280
·
Model: 1.0
·
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IntelliSense Drill Technology
- Primary DI
- B666MCG160280
- Version / Model
- 1.0
- Catalog Number
- MCG160-28S
- 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
- e144815d-6be1-4f1e-afbe-2aed8c60b6c9
Device Description
IntelliSense Drill Bit Size 2.8mm x 160mm
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFG | Bit, Surgical | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43390 | Fluted surgical drill bit, single-use | A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B666MCG160281 | HIBCC | Paperboard box | 10 | In Commercial Distribution | |
| Primary | B666MCG160280 | HIBCC |
Customer Contacts
- Phone
- 3073156403
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143191 | 000 |