Sphäricon TPS cup 52BB

Organization name

Falcon Medical Medizinische Spezialprodukte GmbH

SRN

AT-MF-000001607

Manufacturer status

Active

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

• Do not resterilize
• Do not use if package is damaged
• Consult instructions for use
• Do not re-use
• Caution

Primary placement in Austria; available across 1 country total.

Trade name

Sphäricon TPS cup 52BB

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.

09010098004324

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.

9010030-11-01-10000111UP

Reference / catalog number

11-1004-152

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.falcon-med.com/

Clinical sizes

• 52 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P090803010201PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.