FDA UDI
In Commercial Distribution
🇺🇸 United States
4.5 x 360mm Drill Bit, Side Cutting
DI: 00810074307604
·
Model: 2004-0112
·
Osteocentric Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 4.5 x 360mm Drill Bit, Side Cutting
- Primary DI
- 00810074307604
- Version / Model
- 2004-0112
- Catalog Number
- 2004-0112
- Company Name
- Osteocentric Technologies, Inc.
- Labeler DUNS
- 089645059
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-21
- Public Version
- 1
- Public Version Date
- 2025-10-29
- Public Version Status
- New
- Public Device Record Key
- 51a488e9-411f-41d6-834c-eef420239d8d
Device Description
4.5 x 360mm Drill Bit, Side Cutting
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HTW | Bit, Drill | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32390 | Fluted surgical drill bit, reusable | 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 usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810074307604 | GS1 |
Customer Contacts
- Phone
- 1-800-969-0639
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242691 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.5 | Millimeter | |
| Length | 360 | Millimeter |