8436

Organization name

HTL-Strefa S.A.

SRN

PL-MF-000002198

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW011

  Keep out of reach of children without adult supervision. ! Avoid infections: Before making an injection, clean and disinfect the injection site. Always follow your facility sharps injury prevention guidelines or local regulations. ! Do not use if the seal or needle is damaged or missing or if the shield or outer cap needle appears to be damaged. ! Refer to the instructions for use of the drug and pen injector device for specific storage and handling instructions.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

05907996095186

Basic UDI-DI

B-05907996095186

Reference / catalog number

8436

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Sterile, single-use safety pen needles intended for use with pen injector devices for the injection of drugs.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 0.25 MU50
• Penetration depth — 8 MU50

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

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

• A0101010201HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS