MECRON Shoulder-Hand MaBanfertigung

FDA UDI

Class I (US FDA UDI)

by Darco (Europe) GmbH

Identity

Trade Name: MECRON Shoulder-Hand MaBanfertigung FDA UDI
Generic Name: Shoulder immobilizer/orthosis, reusable FDA UDI
Device Name: Hand FDA UDI
Model / Reference: M4300 FDA UDI
Description: Hand FDA UDI

Identifiers

Catalog Number: M4300 FDA UDI
Primary DI / UDI-DI: 00609271951433 FDA UDI
FDA Product Code: IQJ FDA UDI
GMDN Term: Shoulder immobilizer/orthosis, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3490 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Shoulder immobilizer/orthosis, reusable

MECRON Shoulder-Hand MaBanfertigung by Darco (Europe) GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Shoulder immobilizer/orthosis, reusable.

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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: Darco (Europe) GmbH

Sources (1)

FDA UDI dbb3f90d-f28a-402d-80d0-2d6e9145384f 34 fields · synced Jun 8, 2026