Medicon

FDA UDI

Class I (US FDA UDI)

by Medicon eG. Chirurgiemechaniker-Genossenschaft

Identity

Trade Name: Medicon FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: Miller bone file d/e 18cm FDA UDI
Model / Reference: 26.10.12 FDA UDI
Description: Miller bone file d/e 18cm FDA UDI

Identifiers

Catalog Number: 26.10.12 FDA UDI
Primary DI / UDI-DI: 04046826034801 FDA UDI
FDA Product Code: HTP FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Bone file/rasp, manual, reusable

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

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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 I	Pending data

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Manufacturer

Manufacturer: Medicon eG. Chirurgiemechaniker-Genossenschaft

Sources (1)

FDA UDI 3f14d813-68fa-4002-9e8e-8a69174cd650 34 fields · synced May 31, 2026