10001160

Organization name

Fidia Farmaceutici S.p.A.

SRN

IT-MF-000026988

Manufacturer status

Active

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

• CW007

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

  The product is for intravitreal use only during a vitrectomy surgery. Do not use intravenously or intramuscularly, and do not use as an anti-inflammatory therapy.
• CW999

  The product is single use. The volume contained in the bottle can be used for a single patient during a single surgical procedure at the end of which, the residual content of the bottle must be discarded. Reuse of residual content may result in an ophthalmic infection and/or damage to the patient
• CW999

  Before using VITREAL S during the vitrectomy surgery, check for the presence of any interaction between triamcinolone acetonide and other drugs administered to the patient.
• CW999

  Do not use the product if agglomerates are present in the bottle after vigorous shaking.
• CW999

  The patient should be informed that, after the surgery and until visual acuity returns to normal, it is forbidden to drive vehicles or carry out an activity on dangerous machines

Primary placement in Austria; available across 5 countries total.

Trade name

not provided

UDI-DI code

D-100011602X

Basic UDI-DI

B-100011602X

Reference / catalog number

10001160

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2 MU48

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-100011602X

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• Q02030201OPHTHALMIC DYES