ORTHOFLEX ONE

Organization name

Rompharm Company SRL

SRN

RO-MF-000002517

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date
• CONTRAINDICATIONS: is contraindicated in patients with: • known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate or to any components of ORTHOFLEX ONE • 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 ORTHOFLEX ONE may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. ORTHOFLEX ONE should not be used in patients with known hypersensitivity to derived bovine material.

  OTHER

• Injection site must be properly disinfected (70% alcohol or with another disinfectant). Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronic acid can precipitate in their presence.

  OTHER

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

  OTHER

• As no clinical evidence is available on the use of sodium hyaluronate and chondroitin sodium sulfate in patients with concomitant inflammatory arthropathy (such as rheumatoid arthritis, gouty arthritis), recent orthopedic surgery or trauma at the index joint, the treatment with ORTHOFLEX ONE is not recommended in these patients.

  OTHER

Primary placement in Romania; available across 11 countries total.

Trade name

ORTHOFLEX ONE

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.

05944728007550

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-05944728007550

Reference / catalog number

ORTHOFLEX ONE

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 ONE is a sterile, viscoelastic solution containing two highly purified cross-linked biological polymers, sodium hyaluronate and chondroitin sodium sulfate. ORTHOFLEX ONE consists of sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain and chondroitin sodium sulfate produced from bovine cartilage. ORTHOFLEX ONE is a sterile viscoelastic solution processed using an aseptic processing technique and supplied in a disposable glass syringe delivering 3 mL of solution.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 3 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.