Organization name

Arthrex Inc.

SRN

US-MF-000019271

Manufacturer status

Active

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

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

• CW010

  EUDAMED did not publish a description for this code.
• CW136

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 27 countries total.

Trade name

Arthrex®

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.

00888867308459

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.

0888867TightRopeKnee000FJ

Reference / catalog number

AR-1588RTT

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

ACL TightRope with FiberTag

Additional information URL

https://www.arthrex.com/eDFU

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.

• P09120102ANCHORS, TENDON AND LIGAMENT SYNTHESIS

• Class IIb medical devices in EUDAMED