0032327

Organization name

lege artis Pharma GmbH + Co. KG

SRN

DE-MF-000006175

Manufacturer status

Active

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

• CW010

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

  Allergic reactions to aluminium compounds are possible.
• CW305

  EUDAMED did not publish a description for this code.
• CW318

  EUDAMED did not publish a description for this code.
• CW193

  EUDAMED did not publish a description for this code.
• CW406

  EUDAMED did not publish a description for this code.
• CW397

  EUDAMED did not publish a description for this code.
• CW334

  EUDAMED did not publish a description for this code.
• CW416

  EUDAMED did not publish a description for this code.
• CW132

  The safety data sheet can be downloaded from www.legeartis.de or requested by E-Mail from sicherheitsdatenblaetter@legeartis.de
• CW999

  Contra indications: Do not use on patients with allergy to aluminium compounds.
• CW999

  Do not use with impregnated retraction cords.
• CW135

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

  If heavier capillary bleeding needs to be handled, ORBAT forte should be used for gingival retraction and to stop gingival bleeding
• CW999

  Avoid swallowing.
• CW999

  Do not pour back residues of the solution into the bottle.
• CW999

  Note the instructions under Mode of application!

Primary placement in Germany; available across 5 countries total.

Trade name

not provided

UDI-DI code

111669979879

Basic UDI-DI

B-111669979879

Reference / catalog number

0032327

Issuing entity

IFA

Risk category

Class I

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

No clinical sizes registered for this device.

• Q010204RETRACTION WIRES AND GINGIVAL RETRACTORS

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