37-2150-S

Trade name

not provided

16931918161273

69319181F032KW

Reference / catalog number

37-2150-S

GS1

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Veress Needle_150mm_Sterile_72ea/cs

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.

• K0104VERESS NEEDLES

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

• CW010

  Entry into the abdominal cavity using a sharp instrument can cause major vessel injury and damage to adjacent vital intraperitoneal structures. Before beginning any endoscopic procedure, the surgeon must be familiar with the anatomy pertinent to the procedure and perhaps unique to the individual patient. Although the blunt stylet safety mechanism is intended to reduce the risk of injury related to penetrating vital intraperitoneal structures, correct technique with respect to insertion of the Veress Needle is essential. To further minimize the risk of injury be sure to: • Locate important anatomical objects such as the aorta and both iliac crests to properly place the Veress Needle. • Place the needle with a careful smooth motion in order to avoid impaling structures against the sacral promontory. • Maintain awareness of the patient’s position on the operating table This device is intended for single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing, or resterilization may result in the following complications: • Compromised structural integrity and/or device failure that in turn may result in patent injury, illness or death. • Risk of contamination and/or patient infection or crossinfection that in turn may lead to injury, illness, or death of the patient. Maintain awareness of the patient’s position on the operating table. • A maximum intra-abdominal pressure (IAP) of 30mmHg is recommended for use with this Veress Needle. Products delivered non-sterile which are ultimately for use in sterile environments are intended to be sterilized by the sterile packager. This includes further packaging and sterilization according to the sterile packagers validated processes. In the event of a patient injury related to the device please report the details to the manufacturer and the competent authority of the Member State in shich the user and/or patient is located.