Identity
- Trade Name
- 4.0 x 145mm DRILL BIT CALIBRATED FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- 4.0 x 145mm DRILL BIT CALIBRATED FDA UDI
- Model / Reference
- 324-0034 FDA UDI
- Description
- 4.0 x 145mm DRILL BIT CALIBRATED FDA UDI
Identifiers
- Catalog Number
- 324-0034 FDA UDI
- Primary DI / UDI-DI
- 00810189111189 FDA UDI
- 510(k) Number
- K230764 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.0 Millimeter FDA UDILength — 145 Millimeter FDA UDI
Category: Fluted surgical drill bit, reusable
4.0 x 145mm DRILL BIT CALIBRATED by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fluted surgical drill bit, reusable.
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Cleared under the same submission
K230764 also covers:
- 11 X 100mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 105mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 110mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 75mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 80mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 85mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 90mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11mm HALF TAP CANNULATED — OsteoCentric Technologies,Inc
- 13 X 100mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 105mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 110mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 115mm LAG FASTENER — OsteoCentric Technologies,Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 4f782f1c-be31-4e2f-8c9e-6d349c1f5dc4 37 fields · synced May 31, 2026