DPG2510

Nom de l'organisation

Dermoaroma Italy srl

SRN

IT-MF-000034895

Statut du fabricant

Actif

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• CW999

  Precautions: PRP should be provided to the same patient whom the blood was drawn from (Autologous); tubes must be stored between at room temperature; do not use tubes if foreign matter is present; do not use tubes after their expiration date; do not attempt to clean this product; use prepared platelet concentrate material within 4 hours including drawing blood from patient; be strongly carefull in case of any exposure to biologic samples (through a puncture injury) as there is a potential transmission of hepatitis, HIV (AIDS), or other infectious diseases; discard all blood collection materials in biohazard containers approved for their disposal; be careful during blood transfer from the tube to a syringe in case of vacuum lasting in it.
• CW007

  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.
• CW999

  Safety information: The medical device must only be used by appropriately trained medical or nursing personnel under the medical responsibility, there are no adequate data regarding the use of the product in pregnant or breastfeeding women; experimental data on the safety and efficacy of PRP in children who have not reached skeletal maturity are not available.
• CW999

  Absolute contraindications: Patient unwilling to accept risks; platelet dysfunction syndrome; critical thrombocytopenia; hemodynamic instability; septicemia, local infection at the site of the procedure. Relative contraindications: Consistent use of NSAIDs within 48 hours of procedure; corticosteroid injection at treatment site within 1 month; systemic use of corticosteroids within 2 weeks; tobacco use; recent fever or illness; cancer- especially hematopoietic or of bone; HGB < 10 g/dl; platelet count < 105/ul; there is a general recommendation not to treat during pregnancy or breast-feeding.

Marché principal en Italie ; disponible dans 5 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08056585951802

Basic UDI-DI

B-08056585951802

Numéro de référence/catalogue

DPG2510

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

10ml tube, individually packed in pouch, 25 units per box

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 10 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.

• B0501PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS)