DPG1110D

Nom de l'organisation

Dermoaroma Italy srl

SRN

IT-MF-000034895

Statut du fabricant

Actif

7 avertissements enregistrés — faire défiler le panneau pour tout voir.

• 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.
• 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
• 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.
• 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.
• CW001

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

Marché principal en Italie ; disponible dans 8 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08056585951796

Basic UDI-DI

B-08056585951796

Numéro de référence/catalogue

DPG1110D

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 lidded blister, 6 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)