Libertal Kombi

Trade name

Libertal Kombi

05944728011687

B-05944728011687

Reference / catalog number

KOMBIHYLAN

GS1

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

KOMBIHYLAN is a bio-matrix in the form of a sterile, viscoelastic solution consisting of two highly purified cross-linked biopolymers, sodium hyaluronate and chondroitin sodium sulfate, and N-acetylglucosamine (NAG), a naturally amino sugar. KOMBIHYLAN contains sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain, chondroitin sodium sulfate sourced from bovine cartilage, and NAG sourced from chitin, a naturally long-chain polymer of N-acetylglucosamine. KOMBIHYLAN is a sterile viscoelastic solution processed by aseptic technique and supplied in a disposable glass syringe delivering 2.25 mL of solution.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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

• 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

  Contraindications: is contraindicated in patients with: • known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate, N-acetylglucosamine or to any components of KOMBIHYLAN • pre-existing infections or skin diseases in the area of the intended injection site • known infection of the index joint • known systemic bleeding disorders, bleeding or tendency to bleeding KOMBIHYLAN may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. KOMBIHYLAN should not be used in patients with known allergy to derived bovine material. KOMBIHYLAN should not be used in patients with known allergy to material derived from shrimps, crabs or seafoods.