Organization name

Integra LifeSciences Production Corporation

SRN

US-MF-000009189

Manufacturer status

Active

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

• The Interface Cable is MR Unsafe Do not bring the Interface Cable into the MR environment. Modification of the Interface Cable is not permitted. Unauthorized modifications can cause a malfunction resulting in serious patient injury.

  OTHER

Primary placement in Belgium; available across 22 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.

10381780520733

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.

038178B0066CSS4E

Reference / catalog number

82-6882

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Patient Monitor Interface Cable

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.

• L99SURGICAL INSTRUMENTS, REUSABLE - OTHER

• Class I medical devices in EUDAMED

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