Organization name

Cook Incorporated

SRN

US-MF-000003180

Manufacturer status

Active

Primary placement in Germany; available across 29 countries total.

Trade name

Peel-Away®

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.

00827002044982

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-00827002044982

Reference / catalog number

C-PLI-13.0-38

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

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

Status

On the market

Quantity

1

Additional product description

Introducer Set

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 13 MU170
• 15.5 MU10
• Wire Guide Outside Diameter — 0.038 MU28
• Wire Guide Length — 50 MU10
• Needle Gage — 18 Gage
• Needle Length — 7 MU10

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

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

• C0503CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY

• Class IIa medical devices in EUDAMED

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