ORTHOFLEX Tendon

Organization name

Rompharm Company SRL

SRN

RO-MF-000002517

Manufacturer status

Active

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

• 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.
• CW010

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

  Contraindications: - for patients with ascertained hypersensitivity (allergy) to one of its constituents - for patients with a history of hypersensitivity to gram positive bacterial proteins - for patients with an active infection or skin disease near or around the injection site - for patients who have received another injectable medicine near or around the injection site
• CW999

  Caution should be exercised in patients with known hypersensitivity to medicinal products. The general precautions for peritendinous and intrasheath injections should be observed. ORTOFLEX Tendon should be instilled accurately into the tendon sheath or around the affected tendon. The ultrasound guidance is recommended during injection. Avoid nerve lesions and injections into blood vessels! The procedure should be avoided in patients with known systemic bleeding disorders, or in patients with history of vasovagal reaction or syncope.
• CW999

  Any solution not used immediately after opening must be discarded. Otherwise, the sterility is no longer guaranteed.
• CW032

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

  Do not use if the product is yellow, discoloured or contains precipitates.
• CW999

  Strict aseptic administration technique must be followed to minimize infections at the injection site. Injection site must be properly disinfected (70% alcohol or with another disinfectant). Disinfectants containing quaternary ammonium salts should not be used for skin preparation as hyaluronic acid can precipitate under such conditions.
• CW999

  To be used by a physician only.
• CW135

  EUDAMED did not publish a description for this code.

Primary placement in Romania; available across 32 countries total.

Trade name

not provided

UDI-DI code

05944728007321

Basic UDI-DI

B-05944728007321

Reference / catalog number

ORTHOFLEX Tendon

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

ORTHOFLEX Tendon is a viscoelastic, isotonic, 40 mg/2 ml solution of sodium hyaluronate in a buffered physiological solution comprised of sodium phosphate, sodium chloride, and mannitol at a pH of 7 - 8. The sodium hyaluronate is purified from the bacterial fermentation of a Streptococcus strain. 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