004

Organization name

Provepharm SAS

SRN

FR-MF-000009343

Manufacturer status

Active

4 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.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 2 countries total.

Trade name

not provided

UDI-DI code

03760237160829

Basic UDI-DI

376023716PVDYEVJQ

Reference / catalog number

004

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

ProveDye® is a clear dark blue sterile solution of 0.5% methylene blue (Proveblue®), allowing the surgical visualisation such as intra operative seal tests, leakages visualisation, delineation of fistula tract and visualisation of Sentinel Lymph Nodes (SLN) in oncologic surgery. Reference 004 corresponds to the product presented in a 2ml vial. [EN]

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2 MU03

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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