5-5503-01-33

Organization name

STELLA Kunststofftechnik GmbH

SRN

DE-MF-000007777

Manufacturer status

Active

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04262385230236

Basic UDI-DI

B-04262385230236

Reference / catalog number

5-5503-01-33

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The dosing pipette is intended for dosage of the liquid preparation "MCP-Tropfen" for oral use, in fact together with the adapter, product number 2-4415-00, this inserted in a screw-neck bottle PP28 with a blow-back inside neck finish with a diameter of 19,4 mm and a nominal capacity of 100 ml. The dosing pipette is intended to be marketed as component of finished medicinal products attached to the particular finished medicinal product. In order that it does not come to an automatic drawing back of the piston, the maximum volume (here where applicable up to 5 ml) to be taken must not be greater than the volume of the air space of the bottle. The customer must take care that this requirement must be always kept. This can be done by using a bottle that is big enough respectively that the actual filling volume is small enough. If this here described dosing pipette is used together with other than the above mentioned packaging materials, the user must test fully and on his own responsibility its suitability. The suitability of this here described dosing pipette for the particular liquid preparation is to be tested fully and on the own responsibility by the user. Note: The marketing of a medical device within the economic area of the European Community is only permitted if besides the CE mark the identity number of the Notified Body is applied. The number of the Notified Body is only to be applied on the medical device, if prior to this its corresponding permission is provided.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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