I.CO.S®

Basic Information

• Brand Name: I.CO.S®
• Primary DI: 10381780052159
• Version / Model: 119566ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 5
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 0101a1ad-cbdd-47dd-9954-3e91c1064879
• Distribution End Date: 2025-04-28

Device Description

The cannulated external screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw independently of its main body. The body (internal part) of the 6.5mm compression screw will not be moved. It has a specific spanner slotted-like tip with two threads opposite each other designed to fit the screw head.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
HXX	SCREWDRIVER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248119566ND1	HIBCC
Primary	10381780052159	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6.65mm inner/10mm outer diameter X 184.7mm length