ORTHOFLEX FORTE

Organization name

Rompharm Company SRL

SRN

RO-MF-000002517

Manufacturer status

Active

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

• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date
• P102 – Keep out of reach of children.
• Contraindications: • allergy (hypersensitivity) to any of the components of ORTHOFLEX FORTE • pre-existing infections of the skin region at the injection site • known infection of the index joint • known systemic bleeding disorders.

  OTHER

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

  OTHER

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

  OTHER

• ORTHOFLEX FORTE should not be intra-articularly administered simultaneously or mixed with other products.

  OTHER

• Consult instructions for use

Primary placement in Romania; available across 11 countries total.

Trade name

ORTHOFLEX FORTE

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05944728007222

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-05944728007222

Reference / catalog number

ORTHOFLEX FORTE

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

ORTHOFLEX FORTE is a sterile, viscoelastic solution of sodium hyaluronate. ORTHOFLEX FORTE 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 ORTHOFLEX FORTE 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

• Class III medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.