I.CO.S®

Basic Information

• Brand Name: I.CO.S®
• Primary DI: 10381780045311
• Version / Model: 119546ND
• 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: 6
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 3dd2c58c-7a0a-4dd7-95e8-f19c11e2895c
• Distribution End Date: 2025-04-28

Device Description

The short cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is used to drill the bone for the insertion of the 6.5mm compression screw heads. It must be used through the external protecting sleeve with reference 119552ND.

Device Characteristics

• Single Use: Yes
• 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
HTW	BIT, DRILL	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61235	Cannulated surgical drill bit, single-use	A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248119546ND1	HIBCC
Primary	10381780045311	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.7mm inner/8.5mm outer diameter X 118mm length