Organization name

Integra LifeSciences Production Corporation

SRN

US-MF-000009189

Manufacturer status

Active

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

• Do not interchange the CODMAN© CERTAS Tool Kit (82-8551) components with the components of the CODMAN© CERTAS Therapy Management System TMS (82-8850).

  OTHER

• The Indicator Tool has a precise operating mechanism and is vulnerable to damage if mishandled. Store and carry all components of the Tool Kit in the storage case when not in use to prevent damage. Replace the Indicator Tool immediately if dropped (or suspected of being dropped) to ensure accurate performance. Replacement Indicator Tools are available from your local Integra representative.

  OTHER

Primary placement in Belgium; available across 24 countries total.

Trade name

CODMAN CERTAS®

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.

10381780521327

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.

038178B0076CSS4R

Reference / catalog number

82-8851

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

Codman Certas Tool 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.

• Z12109003CEREBROSPINAL FLUID PRESSURE MONITORING SYSTEMS

• Class I medical devices in EUDAMED

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