Organization name

Integra LifeSciences Production Corporation

SRN

US-MF-000009189

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• This device is not designed, sold, or intended for use except as indicated.

  OTHER

Primary placement in Belgium; available across 23 countries total.

Trade name

CODMAN®

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.

10381780518372

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-10381780518372

Reference / catalog number

82-1735

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

Codman Clear Ventricular CSF Catheter Kit

Additional information URL

https://labeling.integralife.com/

Clinical sizes

No clinical sizes registered for this device.

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

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

• N020199SPINAL CATHETERS AND KITS - OTHER

• Class III medical devices in EUDAMED

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