PV00039

Organization name

i+Med S.Coop.

SRN

ES-MF-000008633

Manufacturer status

Active

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

• CW010

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

  The product is for single use. No reuse; risk of infection
• CW001

  Do not re-sterilize, re-sterilization can affect the physico-chemical properties of the product and compromise its effectiveness and safety.
• CW007

  The product should not be used if the package is damaged or broken.
• CW032

  The product should not be used after the expiration date.
• CW135

  HAXL ONE should not be administered to children.
• CW161

  HAXL ONE should not be administered to pregnant or breastfeeding women.
• CW276

  Do not use with other products containing quaternary ammonium salts as benzalkonium chloride or with any surgical material treated with this type of substances because sodium hyaluronate can precipitate in their presence. In order to prevent any possible interaction, avoid joint administration with other intra-articular products. There is no known interaction with other local anesthetics.
• CW999

  Do not administer HAXL ONE to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer HAXL ONE to patients with acute or chronic dermatological disorders or an inflammatory and / or infectious type skin problem. Do not administer HAXL ONE to patients with coagulation defects and / or who are treated with anticoagulant medication.The use of HAXL ONE in any joint other than the knee and for other conditions has not been studied.HAXL ONE must be injected strictly into the intra-articular space following aseptic injection procedures. HAXL ONE should be administered with sterile Luer-lock needles. Do not inject into a blood vessel or surrounding tissues. To avoid pain after the injection, a recommendation should be given to keep the local site still after the injection.The syringe and the used needle should be discarded in a container provided for this purpose.

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

08437015992754

Basic UDI-DI

B-08437015992754

Reference / catalog number

PV00039

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 4.4 MU03

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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

Certificate health across this manufacturer's portfolio.