281970

Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW008

  Known allergy to binvine collagen.
• CW267

  Bovine collagen.
• CW001

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

  Do not use if the aspect of the cylinders has changed (color, shape, ...)
• CW011

  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.
• CW999

  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.

Primary placement in France; available across 15 countries total.

Trade name

not provided

UDI-DI code

03760243007149

Basic UDI-DI

B-03760243007149

Reference / catalog number

281970

Issuing entity

GS1

Risk category

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.

• Q010399SURGICAL DENTAL DEVICES - OTHER

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