C6DB28-46

Trade name

not provided

UDI-DI code

03700401601338

Basic UDI-DI

B-03700401601338

Reference / catalog number

C6DB28-46

Issuing entity

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

• 46 MU50

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

• P090803010102PRIMARY IMPLANT CEMENTED POLYETHYLENE ACETABULAR CUPS, ONE-PIECE

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.