DPG1105

Organization name

Dermoaroma Italy srl

SRN

IT-MF-000034895

Manufacturer status

Active

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

• 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.
• 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.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 4 countries total.

Trade name

not provided

UDI-DI code

08056585951789

Basic UDI-DI

B-08056585951789

Reference / catalog number

DPG1105

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 lidded blister, 2 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)