Small Wrench (Ø4)

Trade name

Small Wrench (Ø4)

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.

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06941317447505

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.

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B-06941317447505

Reference / catalog number

1504901300

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.

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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.

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Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

It is used in orthopedic surgery.It is provided in non-sterilization packaging, it shall be sterilized before use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• L098002ORTHOPAEDIC INSTRUMENTS KEYS, REUSABLE

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

• CW999

  -To minimize the risk of infection, these devices must be cleaned and sterilized prior to the first use and after every subsequent use. -Assembled instruments will not clean or sterilize completely. Disassemble all instruments prior to cleaning and sterilization. -Using unspecified sterilization cycles or agents may damage the device or result in incomplete sterilization. -Wear appropriate protective equipment: gloves, eye protection, etc. -Clinical orthopedics with the qualification of vice-director physician or above (including vice-director physician) can use this product and give detailed medical advice to patients. -The products may be used in conjunction with other implants and supporting surgical instruments. The products from different manufactures should never be used together. -If tool wear or defect affects normal use, it should be prohibited.

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