I.co.s

FDA UDI

Class II (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: I.CO.S FDA UDI
Generic Name: General internal orthopaedic fixation system implantation kit FDA UDI
Device Name: The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. The I.CO.S screw is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation. This set includes I.CO.S screws that are 4mm in diameter. Instruments are also provided. FDA UDI
Model / Reference: ICOS4INSTSET FDA UDI
Description: The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. The I.CO.S screw is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation. This set includes I.CO.S screws that are 4mm in diameter. Instruments are also provided. FDA UDI

Identifiers

Catalog Number: ICOS4INSTSET FDA UDI
Primary DI / UDI-DI: 10381780064411 FDA UDI
FDA Product Code: HWC FDA UDI
HTY FDA UDI
GMDN Term: General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

I.co.s by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: Newdeal Sas

Sources (1)

FDA UDI 91f8816c-1259-441f-be0f-c55063a0ffe6 37 fields · synced May 30, 2026