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 30 countries total.

Trade name

Percutaneous Access Set With Nitinol Wire Guide

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.

00827002084261

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.

0827002CINC050-181_B22D

Reference / catalog number

NPAS-100-NT

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

Neff

Additional information URL

https://www.cookmedical.eu/

Clinical sizes

• 7 MU170
• 4 MU170
• 18 MU10
• Needle Gage — 22 Gage
• Needle Length — 15 MU10
• Wire Guide outside diameter — 0.018 MU28
• Wire guide length — 60 MU10

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

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

• K010102MINIMALLY INVASIVE SURGERY KITS, SINGLE-USE

• Class IIa medical devices in EUDAMED

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