SZM450-28-L

Organization name

Trulife Inc.

SRN

US-MF-000009657

Manufacturer status

Active

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

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

• CW999

  Never modify the keel. It will void the warranty and can cause bolt or keel failure. If you must alter the form of the foot, be sure not to grind on the keel. Never re-drill the mounting hole. Never modify the spacer. It will void the warranty and may cause failure. Use only bolts supplied by Trulife. Use of unapproved bolts will void the warranty and can cause bolt failure. Looseness of foot bolt may lead to bolt failure and place the patient at risk of injury.

Primary placement in Germany; available across 15 countries total.

Trade name

not provided

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.

00645517872247

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.

00645517FootK3YT

Reference / catalog number

SZM450-28-L

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

—

Additional information URL

https://trulife.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.

• Y062409TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)

• Class I medical devices in EUDAMED