DPG112D

Organization name

Dermoaroma Italy srl

SRN

IT-MF-000034895

Manufacturer status

Active

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

• 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

  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

  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

08056585951826

Basic UDI-DI

B-08056585951826

Reference / catalog number

DPG112D

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

12ml tube, individually packed in lidded blister, 6 units per box

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 12 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)