Organization name

Merck KGaA

SRN

DE-MF-000018777

Manufacturer status

Active

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• Consult instructions for use

Primary placement in Germany; available across 1 country total.

Trade name

Histosec™ pastilles (without DMSO)solidification point 56-58°C embedding agent for histology

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.

04022536158495

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.

4027269115161UT

Reference / catalog number

1151612504

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

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Paraffins are the materials generally used to embed the specimens for histological applications. These paraffins are ready-to-use: “Paraffin pastilles - solidification point about 56-58 °C for histology”, “Histosec™ pastilles - solidification point 56-58 °C embedding agent for histology”, “Histosec™ pastilles (without DMSO) - solidification point 56-58 °C embed - ding agent for histology” The paraffins serve to embed tissue specimens in paraffin. “Paraffin pastilles - solidification point about 56-58 °C for histology” are a highly pure paraffin product. “Histosec™ pastilles - solidification point 56-58 °C embedding agent for his - tology” is a paraffin enriched with polymers and containing DMSO (dimethyl sulfoxide). DMSO increases the rate of penetration of the paraffin and provides additional preservation for the tissue structures. “Histosec™ pastilles (without DMSO) - solidification point 56-58 °C embed - ding agent for histology” is a paraffin enriched with polymers that, for the protection of the user, contains no DMSO (dimethyl sulfoxide). The addition of polymers prevents mottling, air-filled slits between the par - affin crystals that can adversely affect the sectioning procedure. These paraffins are presented in a practical, easy-to-portion pastille form. Using the auxiliary reagents from our portfolio creates the conditions that enable authorized and qualified investigators to make a correct diagnosis at the end of the diagnostic process. In this regard, auxiliary IVD reagents serve inter alia to process human specimen material (e. g. fixing, decalcify - ing, dehydrating, clarifying, paraffin-embedding, mounting, microscoping, archiving). When used together with the corresponding staining solutions, this enables the visualization of cellular structures that are otherwise low in contrast, thus rendering them evaluable under the optical microscope. Further examinations may be necessary to reach a definitive diagnosis.

Additional information URL

https://www.sigmaaldrich.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.

• W01030704EMBEDDING MEDIA (HISTOLOGY/CYTOLOGY)

• IVDR Class A medical devices in EUDAMED

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