Organization name

Integra LifeSciences Production Corporation

SRN

US-MF-000009189

Manufacturer status

Active

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

• Instruments should not be used for anything other than their intended use.

  OTHER

• Consult individual national infection control/prevention protocols for specific guidance regarding processing medical devices with suspected exposure to CJD.

  OTHER

• If any device is/was used in a patient with, or suspected of having Creutzfeld Jakob Disease (CJD), the device cannot be reused and must be destroyed after exposure, as the instruments have not been validated to withstand the chemical and thermal exposure recommended to eradicate prions.

  OTHER

Primary placement in Belgium; available across 16 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.

10381780509165

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-10381780509165

Reference / catalog number

20-1038

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

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

Status

On the market

Quantity

1

Additional product description

CODMAN Scalp Clip Applier

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.