Safety Needle

Organization name

"STERIPACK MEDICAL POLAND" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

SRN

PL-MF-000006939

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW009

  Device is intended for single use only. Do not re-sterilize and/or reuse the device as this can potentially result in a compromised device performance and the increased risk of injury, inappropriate sterilization, and cross contamination.
• CW001

  Device is intended for single use only. Do not re-sterilize and/or reuse the device as this can potentially result in a compromised device performance and the increased risk of injury, inappropriate sterilization, and cross contamination.

Primary placement in Belgium; available across 1 country total.

Trade name

Safety Needle

UDI-DI code

05907527942002

Basic UDI-DI

05907527942SafetyNeedleYQ

Reference / catalog number

7527942002

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Safety Needle is a single-use device with a robust shield that can be activated by one-hand via multiple methods (finger, thumb or flat surface) for clinical flexibility. The safety shield is an integral part of the needle hub which provides an audible and tactile click to confirm safety activation. The safety needle can be used with other Luer or Luer Lock connection devices. Once the safety needle is used, the safety shield should cover the needle tip and be discarded in an approved sharps container.

Additional information URL

https://www.ensera.com/wp-content/uploads/IFU-DWC125-05-001.pdf

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.

• A0101010101HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS

Certificate health across this manufacturer's portfolio.