50020

Organization name

Contura International A/S

SRN

DK-MF-000002018

Manufacturer status

Active

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

• CW999

  CONTRAINDICATIONS Arthrosamid® should not be injected: • If an active skin disease or infection is present at or near the injection site. • If the joint is infected or severely inflamed. • If the patient has previously received treatment with a different non-absorbable injectable/implant in the same knee. • If the patient has previously received treatment with an absorbable intra-articular injectable (such as hyaluronic acid) that is not yet expected to be absorbed, according to manufacturer’s information for the specific product. • If the patient has received a knee alloplasty or has any foreign material in the knee. • If the patient has undergone knee arthroscopy within the last 6 months. • In patients with uncontrolled hemophilia or in patients with uncontrolled anti-coagulation treatment. Do not subsequently inject a different non-absorbable implant in the injected knee.
• CW999

  WARNINGS • Do not inject Arthrosamid® intravascularly, extra-articularly or in the tissue of the capsule. • Do not inject corticosteroids along with Arthrosamid®. • Do not inject any pharmaceuticals or biological substances along with Arthrosamid®.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

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

  EUDAMED did not publish a description for this code.

Primary placement in Denmark; available across 16 countries total.

Trade name

not provided

UDI-DI code

05704101500203

Basic UDI-DI

5704101Arthrosamid3K

Reference / catalog number

50020

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Arthrosamid® is a non-absorbable, biocompatible, injectable, transparent hydrogel for intra-articular injection. Arthrosamid® consists of 2.5 % cross-linked polyacrylamide and 97.5 % non-pyrogenic water. Arthrosamid® is supplied in a pre-filled, sterile, 1 mL syringe, sealed with a Tip Cap in a Luer Lock fitting.

Additional information URL

https://contura.com/orthopaedics/

Clinical sizes

• 1 MU48

• P900403NON-RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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

This device is not currently linked to any other device.

Certificate health across this manufacturer's portfolio.