Bulkamid® Rotatable Sheath

Organization name

Contura International A/S

SRN

DK-MF-000002018

Manufacturer status

Active

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

• CW010

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

  Bulkamid® Urethral Bulking System is contraindicated in: • Patients suffering from acute cystitis or urethritis. • Patients who have active Herpes Genitalis. • Patients with damaged tissue in the urethra.

Primary placement in Netherlands; available across 25 countries total.

Trade name

Bulkamid® Rotatable Sheath

UDI-DI code

05704101100472

Basic UDI-DI

5704101BURSY8

Reference / catalog number

10047

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Bulkamid® Rotatable Sheath is a guidance device used for injecting Bulkamid® Hydrogel in the urethral sub-mucosal tissue under visual control. The Bulkamid® Rotatable Sheath is a 125 mm long device with a working channel for the needle, access lumen for the optic device, and water tubes with flow regulators and Luer lock connector for the inflow of water.

Additional information URL

https://contura.com/urinaryincontinence/

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.

• U0780DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES

Certificate health across this manufacturer's portfolio.