SLS493-22-R-1

Organization name

Trulife Inc.

SRN

US-MF-000009657

Manufacturer status

Active

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

• CW999

  Warnings and/or contraindications specified for the assembled prosthesis, include, but are not limited to: • Patient must always wear shoes when using the Solas outdoors. • Rinse the Solas thoroughly with fresh water after any contact with salt water, sand or other contaminates, and dry thoroughly. Do not immerse foot in water. • Never disassemble the Solas, excluding procedures specifically referred to in the install guide. • Discontinue use and consult your physician or prosthetist if the prosthesis causes pain or injures you in any way. • Discontinue use and consult your prosthetist if any part of the prosthesis starts to make noise. • Do not attempt to adjust or service the prosthesis except as advised by your prosthetist. • Inform your prosthetist if you lose or gain a significant amount of weight. • Have the prosthesis serviced at regular intervals specified by the prosthetist. • Trulife’s feet are manufactured and tested for a particular weight and activity level. Use by an amputee, other than the one for whom it was originally manufactured, may be dangerous and will void any written or implied warranty.

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.

00645517891828

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.

00645517FootK4YV

Reference / catalog number

SLS493-22-R-1

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

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