JOINTEC

Organization name

Rompharm Company SRL

SRN

RO-MF-000002517

Manufacturer status

Active

10 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.
• CW007

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW135

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

  Contraindications: • allergy (hypersensitivity) to any of the components of JOINTEC • pre-existing infections of the skin region at the injection site • known infection of the index joint • known systemic bleeding disorders.
• CW999

  The product is administered only if the solution is clear.
• CW999

  Sodium hyaluronate should be administered in the synovial joint space only by medical professionals trained in intra-articular administration technique.
• CW999

  JOINTEC should not be intra-articularly administered simultaneously or mixed with other products.

Primary placement in EL; available across 1 country total.

Trade name

not provided

UDI-DI code

05944728007185

Basic UDI-DI

B-05944728007185

Reference / catalog number

JOINTEC

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

JOINTEC is a sterile, viscoelastic solution of sodium hyaluronate. JOINTEC contains 30 mg/2 ml of sodium hyaluronate with a molecular weight of 1.5 - 2.4 million daltons dissolved in physiological saline solution with the average osmolality of 335 milliosmoles, in a single-use syringe. The sodium hyaluronate is purified from the bacterial fermentation of a Streptococcus strain. Each milliliter of JOINTEC contains 15 mg of sodium hyaluronate, sodium chloride and water for injections. Sterile by moist heat.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2 MU03

• 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