DROP CONTROL DEVICE

Organization name

GEM SRL

SRN

IT-MF-000012892

Manufacturer status

Active

4 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.
• CW999

  The device must only be used by experienced medical practitioners who are suitably trained to use the device.The device must only be used with the Glubran® 2 medical device.

Primary placement in Italy; available across 30 countries total.

Trade name

DROP CONTROL DEVICE

UDI-DI code

08031902000104

Basic UDI-DI

80319028AD

Reference / catalog number

G2 DCD-210-8T

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Device consisting of: - Catheter with luer connection complete with blunt tip needle for placement of Glubran® 2 surgical glue only. - 2.5 ml luer syringe complete with blunt tip needle.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• C900180HAEMOSTASIS SYSTEMS - ACCESSORIES

Certificate health across this manufacturer's portfolio.