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OIC Variable Angle Small Fragment Locking Plate System

FDA UDI

Class II (US FDA UDI)

by Orthopaedic Implant Company, The

Identity

Trade Name
OIC Variable Angle Small Fragment Locking Plate System FDA UDI
Generic Name
Fluted surgical drill bit, single-use, non-sterile FDA UDI
Device Name
DRILL BIT 1.8MM X 80MM QC FDA UDI
Model / Reference
DR18-080C FDA UDI
Description
DRILL BIT 1.8MM X 80MM QC FDA UDI

Identifiers

Primary DI / UDI-DI
10811998034000 FDA UDI
510(k) Number
K140357 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Fluted surgical drill bit, single-use, non-sterile 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 80 Millimeter FDA UDI
Outer Diameter — 1.8 Millimeter FDA UDI

Category: Fluted surgical drill bit, single-use, non-sterile

OIC Variable Angle Small Fragment Locking Plate System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Fluted surgical drill bit, single-use, non-sterile.

Cleared under the same submission

K140357 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopaedic Implant Company, The

Sources (1)

  • FDA UDI eada45e6-e596-4040-a13f-1531d41dd2db 36 fields · synced May 30, 2026