Organization name

Cordis US Corp.

SRN

US-MF-000020031

Manufacturer status

Active

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

• Consult instructions for use

  Consult instructions or electronic instructions for use

Primary placement in Ireland; available across 32 countries total.

Trade name

AVANTI™+ Transradial Introducer Kit

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

10705032010290

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

07050320000000000000011C6

Reference / catalog number

504-617Z

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

A catheter sheath introducer (CSI) has a hydrophobic coating and facilitates percutaneous entry of an intravascular device. Color coding indicates the French size of the largest intravascular device that will pass through the CSI. The availability of French sizes varies per product line. Refer to product catalog for availability. French Color 4 Red, 5 Gray, 6 Green, 7 Orange. Vessel Dilator (Included): A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The vessel dilator has a hydrophobic coating to facilitate insertion and withdrawal during vessel access. Needle (Included): A needle is provided to facilitate entry into the artery. Refer to product labeling for the size. Mini-Guidewire (Included): A mini-guidewire is provided for maintaining access to the puncture site upon removal of the needle and before the insertion of the CSI. Refer to product labeling for the size.

Additional information URL

https://www.cordislabeling.com/

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 10705032010290× 1 unitBase unit
  • 20705032010297× 5 units

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

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

• C0502CARDIOVASCULAR INTRODUCER SHEATHS, VALVED

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.