Organization name

Cook Incorporated

SRN

US-MF-000003180

Manufacturer status

Active

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

• CW007

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

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 31 countries total.

Trade name

Stiff Fixed Core Wire Guide Double Flexible

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.

00827002535572

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.

0827002CINC011-042_AG6

Reference / catalog number

AS-038145-DF

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

Amplatz

Additional information URL

https://www.cookmedical.eu/

Clinical sizes

• 0.038 MU28
• 145 MU10
• Tip Length — 5 MU10

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

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

• U0602UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC

• Class IIa medical devices in EUDAMED

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