Organization name

Philips Ultrasound LLC

SRN

US-MF-000002237

Manufacturer status

Active

Primary placement in Germany; available across 32 countries total.

Trade name

Tool Connection Unit

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.

00884838081253

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.

0884838BM436T3

Reference / catalog number

989605464311

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

This product is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure. Installation, use, and operation of this product are subject to the law in the jurisdictions in which the product is used. Install, use, and operate the product only in such ways that do not conflict with applicable laws or regulations, which have the force of law. Use of the product for purposes other than those intended and expressly stated by Philips, as well as incorrect use or operation, may relieve Philips or its agents from all or some responsibility for resultant noncompliance, damage, or injury.

Additional information URL

https://www.usa.philips.com/healthcare/support/resource-center/results?sort=relevancy&f:@ps_contenttype=%5bInstruction%20for%20Use%5d&f:@ps_language=%5bEnglish%20%28US%29%2cEnglish%5d&f:@ps_modality=%5bUltrasound%5d

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.

• Z12011480SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED

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