urogold100

Organization name

MTS Medical AG (Aktiengesellschaft)

SRN

DE-MF-000005447

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  • Do not use the device in patients with pacemakers or implantable defibrillators. • Do not use the device in patients who are using devices which are sensitive to electromagnetic radiation. • Do not use the device in confirmed or suspected pregnancy. • Do not use the device for the treatment of vertebrae, skull bones and ribs. • Do not adjust the therapy focus on internal organs (especially lungs). • Do not use the device for the treatment of patients with tumors. • Do not use the device for the treatment of patients with coagulation disorders or if the patient currently receives anticoagulants. • Do not adjust the therapy focus on large nerves. • Do not use the device for the treatment of patients younger than 18 years or of patients with open epiphyseal plates. • Do not adjust the therapy focus on large vessels. • Do not use the device for extracorporeal shock wave lithotripsy.

Primary placement in Germany; available across 5 countries total.

Trade name

urogold100

UDI-DI code

04260484571502

Basic UDI-DI

426048457OW100OW100SZB

Reference / catalog number

1000003

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

The urogold100 is a non-invasive shock wave medical device under the model OW100, which is used together with its accessories for urological indications.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12160101EXTRACORPOREAL LITHOTRIPTERS

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