Organization name

Cook Incorporated

SRN

US-MF-000003180

Manufacturer status

Active

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

• Consult instructions for use
• Do not use if package is damaged

Primary placement in Germany; available across 25 countries total.

Trade name

not provided

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.

00827002082861

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.

B-00827002082861

Reference / catalog number

RMT-14XT-50.5-LABS-200

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 III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Liver Access and Biopsy Needle

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• needle length — 60 MU10
• sheath diameter outer — 2.2 MU50
• sheath length — 53.5 MU10
• introducer diameter outer — 7 MU170
• needle diameter outer — 1.1 MU50

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

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

• A010299BIOPSY NEEDLES AND KITS - OTHER

• Class III medical devices in EUDAMED

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