FDA UDI
In Commercial Distribution
🇺🇸 United States
4.0 x 125mm Drill Bit Cann AO
DI: 00810074305013
·
Model: 320-80023
·
Osteocentric Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 4.0 x 125mm Drill Bit Cann AO
- Primary DI
- 00810074305013
- Version / Model
- 320-80023
- Catalog Number
- 320-80023
- Company Name
- Osteocentric Technologies, Inc.
- Labeler DUNS
- 089645059
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-06
- Public Version
- 2
- Public Version Date
- 2025-11-27
- Public Version Status
- Update
- Public Device Record Key
- 75378b9c-ff3d-4bb8-b3f8-567e04a07e93
Device Description
4.0 x 125mm Drill Bit Cann AO
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
- 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 |
|---|---|---|---|---|
| 11332 | Cannulated surgical drill bit, reusable | A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810074305013 | GS1 |
Customer Contacts
- Phone
- 1-800-969-0639
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170021 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.0 | Millimeter | |
| Length | 125 | Millimeter |