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.

• CW010

  【Contraindications】 Do not use for tissues where have ischemia or necrosis. 【Warnings】 1. According to operation requirements, 1-5 pcs reload units can be replaced during the same operation, and each reload unit is separately packed. 2. This device can only be used by surgeons who have been fully trained and are familiar with operation skills. 3. 2.5 staple height model is suitable for compressed tissue thickness 0.7-1.0mm. 3.5and 3.8 staple height model is suitable for compressed tissue thickness 1.0-1.7mm. 4.5 staple height model is suitable for compressed tissue thickness 1.6-2.4mm. 4. After removing the device, it is necessary to check the bleeding of the sutured tissue. If there is bleeding, appropriate methods must be used to stop the bleeding. 5. Please examine the package before using. Do not use if package is damaged. 6. This device is sterilized with using ethylene oxide. Do not resterilize. 7. This product is a disposable device and it is strictly prohibited to reuse it. 8. The validity of this product is three years. Please check whether the product is within the validity period before use. It is strictly prohibited to use the product beyond the validity period.

Primary placement in XI; available across 32 countries total.

Trade name

Disposable Linear Cutter Stapler Reload Unit

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.

06971767870547

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-06971767870547

Reference / catalog number

80ZC

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Refer to IFU

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.

• H020201010102SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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