Medicon

FDA UDI

Class II (US FDA UDI)

by Medicon eG. Chirurgiemechaniker-Genossenschaft

Identity

Trade Name: Medicon FDA UDI
Generic Name: Sternal fixation device FDA UDI
Device Name: Ti Sternal Fixation screw lock 2.4x20mm self-dr li-blue P/10 FDA UDI
Model / Reference: 54.80.20 FDA UDI
Description: Ti Sternal Fixation screw lock 2.4x20mm self-dr li-blue P/10 FDA UDI

Identifiers

Catalog Number: 54.80.20 FDA UDI
Primary DI / UDI-DI: 04046826494841 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Sternal fixation device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Sternal fixation device

Medicon by Medicon eG. Chirurgiemechaniker-Genossenschaft — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sternal fixation device.

STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
Vanguard® — Biomet Orthopedics, Inc. · Class I
ARIX Sternal System Bone Screw — Jeil Medical Corporation · Class II
ARIX Sternal System Bone Plate — Jeil Medical Corporation · Class II
SternaFuse® Fixation System — FUSION INNOVATIONS · Class II
Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II

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: Medicon eG. Chirurgiemechaniker-Genossenschaft

Sources (1)

FDA UDI 9f2c145b-4401-4c11-a771-2216fad7d11f 35 fields · synced Jun 8, 2026