DPG2510

Organization name

Dermoaroma Italy srl

SRN

IT-MF-000034895

Manufacturer status

Active

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

• 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 did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this 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.

Primary placement in Italy; available across 5 countries total.

Trade name

not provided

UDI-DI code

08056585951802

Basic UDI-DI

B-08056585951802

Reference / catalog number

DPG2510

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

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

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 10 MU48

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• B0501PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS)