Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

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

• Consult instructions for use
• Biological risks

  Known allergy to binvine collagen.

• Contains biological material of animal origin

  Bovine collagen.

• Do not resterilize
• Do not use if the aspect of the cylinders has changed (color, shape, ...)

  OTHER

• Caution

  Do not moisten or autoclave. In the absence of specific studies, the use of this product in pregnant and breastfeeding women can only be done if the practionner deems this necessary.

• The use of this product imperatively erquires first: an interview to known the background, current therapies and history of the patient. Take into account the particular risks in patient with coagulation disorders. A biological glue must be used in addition to the local hemostatic agent and sutures in the rare cases where the Internationalized Normalized Ratio (INR) is greater than 3 and/or if the type of intervention is classified as high hemorrhagic risk.

  OTHER

Primary placement in France; available across 15 countries total.

Trade name

ETIK COLLAGENE

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.

03760243007149

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-03760243007149

Reference / catalog number

281970

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

Box of 25 mainly type I bovine collagen cylinders (cylinder dimension : diameter 10 mm ± 1 mm, height 16 mm ± 1 mm). Unit sterile blister packaging (5 blisters of 5 cylinders). Sterilisation by gamma irradiation. Complies with Annex I of Regulation 722/2012.

Additional information URL

https://www.acteongroup.com/documentation

Clinical sizes

No clinical sizes registered for this device.

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

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

• Q010399SURGICAL DENTAL DEVICES - OTHER

• Class III medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.