FILLAH HYDRA 1,4%

Trade name

FILLAH HYDRA 1,4%

08437027750052

B-08437027750052

Reference / catalog number

-

GS1

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1 MU48

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

9 warnings recorded — scroll inside the panel to see all entries.

• P102 – Keep out of reach of children.

  The product should not be administered to children. Keep out of children’s reach.

• P263 – Avoid contact during pregnancy/while nursing.

  The product should not be administered to pregnant or breastfeeding women.

• Do not administer to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer to patients with acute or chronic dermatological disorders or an inflammatory and / or infectious type skin problem. Do not administer to patients with coagulation defects and / or who are treated with anticoagulant medication. The producto should not be injected into blood vessels or eyelids; intravascular injection may produce embolization, occlusion of the vessels, ischemia, blindness or infarction. The product should be administered exclusively by intradermal injection following a strict aseptic procedure. The product should be administered with sterile Luer-lock needles (as supplied with the product). It is recommended that the patient do not wear makeup for 12 hours after the injection and avoid prolonged exposure to the sun, to ultraviolet rays, at temperatures below 0°C, as well as the sauna or Turkish bath during two weeks following the injection. The syringe and the used needle should be discarded in a container provided for this purpose.

  OTHER

• Consult instructions for use