Organization name

CooperSurgical, Inc.

SRN

US-MF-000002607

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 32 countries total.

Trade name

Carter-Thomason® CloseSure System

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.

60888937000094

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.

0888937TD060ZM

Reference / catalog number

CTI-512N

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

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

Status

On the market

Quantity

1

Additional product description

Carter-Thomason® CloseSure System 1 Carter-Thomason Suture Passer 2 - Pilot Guides

Additional information URL

No additional information URL provided by the manufacturer.

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.

• H900899SINGLE-USE INSTRUMENTS FOR SUTURES - OTHER

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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