OPERO gown SMMMS non-woven surgeon’s gown – reinforced, sterile

Trade name

OPERO gown SMMMS non-woven surgeon’s gown – reinforced, sterile

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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06971705248339

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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697170524Gowns05X5

Reference / catalog number

W219100070_2080

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

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

Status

On the market

Quantity

1

Additional product description

XXXL

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.

• T020402REINFORCED SURGICAL GOWNS

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

• CW999

  Product for single use. Do not reuse. Do not resterilize. Do not use if the product/package is damaged. Do not use after the expiry date stated on the package label. For use by qualified personnel (professional users). "

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