INN48

Organization name

Innate s.r.l.

SRN

IT-MF-000026730

Manufacturer status

Active

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

• 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.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  Is suitable only for intra-articular injections and must only be dispensed by a doctor who has received specific training on the intra-articular injections technique. The device must not be used in pregnant or breastfeeding women, as has not been tested in such cases. The device must be not be used in patients with ascertained individual hypersensitivity to any of the ingredients of the product. As no clinical experience is available for the use of Hyaluronan in children, treatment with Promovia Hydro Balance is not recommended in these cases. After the intra-articular injection it is advisable to recommend to the patient to avoid physical activities demanding stress for the articulation and resume normal activities after a few days. After the intra-articular injection it is advisable to recommend to the patient to avoid driving for at least 48 hours. Is a disposable product, the quality and sterility are guaranteed only if the syringe is sealed. Before use, check the integrity of the syringe and the expiration date. The product should not be injected in the presence of a infected or severely inflamed joint. The infiltration must be avoided in the case of infection in place or inflammatory conditions of the skin in proximity of the injection. Do not use the product if the package is already opened or damaged. The assembled syringe must be discarded immediately after use, regardless of whether or not the solution has been completely administered. After use, dispose according to applicable national practice. For additional information consult instruction for use

Primary placement in Italy; available across 6 countries total.

Trade name

not provided

UDI-DI code

08051040330321

Basic UDI-DI

B-08051040330321

Reference / catalog number

INN48

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

Is a synovial fluid substitute which, thanks to its viscoelastic and lubricant properties, promotes the restoration of rheological conditions of the joints, altered in degenerative or post-traumatic conditions. The product, improving the characteristics of the synovial fluid, exerts a protective action of the joints and helps the improvement of joint function and the reduction of pain symptoms. It acts only at the joint where it is injected, without exerting any systemic action

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.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

Certificate health across this manufacturer's portfolio.