QH18-130

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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03700401605503

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

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B-03700401605503

Reference / catalog number

QH18-130

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://biotechni.com/notice/

Clinical sizes

• 18 MU50
• 130 MU50

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P090804030201REVISION UNCEMENTED FEMORAL STEMS, WITH FIXED NECK

1 warning recorded — scroll inside the panel to see all entries.

• CW018

  Patients should be warned of these contraindications. Contraindications include: Conditions which can severely affect the success of the implantation: • Any local, acute, or chronic infection. Any infectious illness. Fever or leucocytosis. • Systemic and metabolic disorders. Any mental or neuromuscular disorder. • Deficient bone stock, osteopenia and/or severe osteoporosis. • Drug, tabacco and/or alcohol addiction and/or abuse. • Non terminated skeletal development. • Intense physical activity • Proved or suspect sensitivity to materials • Tumor unresectable or residual. • Pregnancy, obesity or overweight (BMI >25) These contraindications are of general order and not exhaustive, and the surgeon will have to evaluate each patient, in order to determine the risks specific to the surgery and the benefit for the patient

No certificate specifically references this device's Basic UDI-DI.