Identity
- Trade Name
- OIC Intramedullary Screw System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- 2.6mm x 90mm CANNULATED DRILL BIT FDA UDI
- Model / Reference
- DR26-090C FDA UDI
- Description
- 2.6mm x 90mm CANNULATED DRILL BIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811998031832 FDA UDI
- 510(k) Number
- K223761 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.6 Millimeter FDA UDILength — 90 Millimeter FDA UDI
Category: Fluted surgical drill bit, single-use
OIC Intramedullary Screw System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223761 also covers:
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
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 II | Pending data |
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Manufacturer
- Manufacturer
- Orthopaedic Implant Company, The
Sources (1)
- FDA UDI 1b990eb1-d8ea-49eb-a2d2-756dfe1cd0e4 36 fields · synced May 30, 2026