PS001.1.1

Organization name

Jointherapeutics srl

SRN

IT-MF-000028991

Manufacturer status

Inactive

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• CW010

  EUDAMED did not publish a description for this code.
• CW267

  Chitosan
• 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.
• CW129

  Local or systemic allergic reactions may occur, mainly in patients who are hypersensitive to one or more of the ingredients in the device. Signs and symptoms of an allergic reaction, such as skin rash, itching or hives, however, are considered to be rare. Main ingredient: 1 ml of solution contains 12.5 mg of sodium hyaluronate (1.25 %). Other ingredients: sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, potassium chloride, water for solution for injection and Chitlac®.
• CW083

  Local or systemic allergic reactions may occur, mainly in patients who are hypersensitive to one or more of the ingredients in the device. Signs and symptoms of an allergic reaction, such as skin rash, itching or hives, however, are considered to be rare. Main ingredient: 1 ml of solution contains 12.5 mg of sodium hyaluronate (1.25 %). Other ingredients: sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, potassium chloride, water for solution for injection and Chitlac®.
• CW136

  EUDAMED did not publish a description for this code.
• CW036

  Do not use the product in combination with disinfectants containing quaternary ammonium salts (such as benzalkonium chloride) as hyaluronic acid is known to precipitate in the presence of this. No interactions with other local or locoregional anaesthetics.
• CW030

  • INGENERA® bio must be used at room temperature and only by qualified healthcare professionals. • Treat the injection site with a suitable antiseptic solution. • Observe all regulations regarding asepsis and infiltration techniques; • INGENERA® bio is designed for injections in the surface dermis or at the dermo-epidermal junction. • Use the most appropriate administration technique (for example, the linear or micro-papular technique). For the treatment of extensive areas, the linear threading or cross-hatching technique is recommended. • After administration, gently massage the area to further spread the product. • It is advisable to provide customised courses of treatment according to the needs of the patient.

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

80569925800080

Basic UDI-DI

B-80569925800080

Reference / catalog number

PS001.1.1

Issuing entity

GS1

Risk category

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

2 mL Cardboard box containing one pre-filled and graduated glass syringe, sterilized by moist heat, with Luer Lock adapter, in thermoformed blister, back-stop, two disposable needles 30G 1/2 "ETO sterilized (CE0123), one package leaflet, two / three adhesive traceability labels.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

This device is not currently linked to any other device.