Organization name

Wuxi Beien Surgery Device Co., Ltd.

SRN

CN-MF-000017684

Manufacturer status

Active

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

• Consult instructions for use

  【Contraindications】 This device is not intended for use when minimally invasive techniques are contraindicated. 【Precautions】 1. The device cannot be used in general contraindications of endoscopic surgery. 2. The device is used by professional surgeons who accepts training only. 3. The device has been sterilized with EO for single use only. It must be discarded after use. Do not disinfect again. 4. Examine the package prior to use, do not use if package damaged. 5. Do not insert the device forcefully in case of patient whose abdominal wall is firm. 6. Do not insert the device too deeply into abdominal cavity where organs or vessels exist. For pubis puncture,insert the device 3cm over pubic bone and avoid the position of fundus of bladder.

Primary placement in XI; available across 32 countries total.

Trade name

Disposable Endoscopic Trocars

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.

06971767872220

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.

B-06971767872220

Reference / catalog number

1501SD

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

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

【Indication for Use】 This Device is intended to use in endoscopic surgery to set up an accessible channel during abdominal operation.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• K01010180TROCAR, SINGLE-USE - ACCESSORIES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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