Organization name

Cook Incorporated

SRN

US-MF-000003180

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 29 countries total.

Trade name

Advance® Enforcer® 35

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.

00827002352483

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-00827002352483

Reference / catalog number

ASB5-35-50-6-4

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

Focal-Force PTA Balloon Catheter

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 MU170
• 50 MU10
• 0.035 MU28
• inflated balloon diameter — 6 MU50
• inflated balloon length — 4 MU10
• inflation device — 10 MU126

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

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

• C010402020101PTA BALLOON DILATATION CATHETERS

• Class IIa medical devices in EUDAMED

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