OIC Intramedullary Nail System

Basic Information

• Brand Name: OIC Intramedullary Nail System
• Primary DI: M69601IM340
• Version / Model: 01-IM34
• Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE
• Labeler DUNS: 070061160
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-01
• Public Version: 4
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: a8f05651-0bcd-432e-a275-6198781a5222

Device Description

4.2 MM DRILL SLEEVE

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
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47913	Bone-nailing spacer	A nonimplantable, surgical device intended to provide the correct spatial distance between an intramedullary bone nail and another device (e.g., aiming arm, implantable spacer) during bone nail implantation. It is typically a rod-like device made of high-grade stainless steel or synthetic materials. It is not a copy of a final implant (i.e., not a trial). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M69601IM340	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150655	000