Volomis SOFT

Nom de l'organisation

Dermoaroma Italy srl

SRN

IT-MF-000034895

Statut du fabricant

Actif

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• CW999

  Contraindications: 1) Use of Dermal Filler in patients exhibiting autoimmune connective tissue disease is not recommended. Dermal Filler is contraindicated in infected or non - vascular surgical sites, unless specifically prescribed by their physician. 2) Patients should avoid non-steroidal anti- inflammatory drugs, including Aspirin®, for the two weeks preceding the treatment with Volomis. 3) Ancillary agents that may cause inflammation at the treatment site should be avoided. 4) Dermal Filler should not be used in periocular line correction or glabellar contouring. 5) Do not apply it to the following patients: patients who have been given aggregation inhibitors, anticoagulants, immunosuppressive medications, etc. 6) Do no apply to the patients with allergic disease, autoimmune disease, sarcoid granulomatous diseases, and Osler's endarteritis. 7) Do not use in patient using pacemaker or active implantable medical devices for suggestions and tensions during the treatment. 8) Do not apply to the pregnant and lactating women. 9) Do not apply to the infants and juveniles.
• CW999

  General warnings: 1) Do not apply the product to locations that have been treated by fillers lately or by fillers not reabsorbed. 2) Do not apply it to the other locations (breast, for example) besides the face. 3) Do not inject it into tendons, muscles, or bones. 4) Do not inject it into blood vessel. 5) Do not overuse. 6) Do not apply it to people who have a hypersensitivity to the ingredient of the product (Hyaluronic acid). 7) Do not apply it to inflammatory or infected skins. 8) Do not use it in combination with laser, chemical peeling or skin scraping treatment. 9) Long term safety and effectiveness of Dermal Filler beyond 6 months have not been investigated in clinical trials. 10) Re-administration interval of Dermal Filler is recommended about 6 months. 11) Appearance of a product should be checked before use and if it is with any abnormality, it should not be used. 12) When injecting to the patient, apply force slowly and uniformly to the plunger rod.
• CW032

  EUDAMED n'a pas publié de description pour ce code.
• CW011

  EUDAMED n'a pas publié de description pour ce code.
• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW009

  EUDAMED n'a pas publié de description pour ce code.
• CW001

  EUDAMED n'a pas publié de description pour ce code.
• CW007

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  Safety information: The medical device must be used by trained physicians (experts trained who can use this medical device) only, in an operating room or at a clean room of hospital.
• CW999

  Precautions: 1) Dermal Filler is packaged for single patient use. 2) As with all transcutaneous procedures, Volomis implantation carries a risk of infection. 3) Dermal Filler implants should be not used in patients on immunosuppressive therapy. 4) The safety and effectiveness of Dermal Filler implantation for use in lip augmentation has not been established. 5) No long-term studies have been conducted to evaluate the potential of Dermal Filler to cause cancer. Potential risks to an embryo or fetus are unknown at this time and there may be other risks or side effects that are also unknown at this time. 6) In case of the product that includes needle, use the needle provided with the product. 7) In case of the product that does not include needle, the qualified doctor can select and use the needle gauge that fits the filler (recommended needles: 23 G normal wall needle, 25 G extra thin wall needle, 20 G – 30 G cannula).

Marché principal en Italie ; disponible dans 3 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08056585950553

Basic UDI-DI

B-08056585950553

Numéro de référence/catalogue

Volomis SOFT

Entité d'attribution

GS1

Catégorie de risque

Classe III

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

1ml syringe, individually packed in lidded blister, box of 2 units with needles

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 1 MU48

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES