Organization name

Changzhou Tongchuang Medical Instrument Technology Co., Ltd.

SRN

CN-MF-000028788

Manufacturer status

Active

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

• CW999

  1.The stapler is disposable and can be used after opening the sterile package. Once the package is found to be damaged, it must not be used. When in use, the sterile techique shall be strictly executed. 2.The stapler is sterilized by ethylene oxide, and is delivered in a sterile sealed package. The validity period is three years from the date of sterilization. Products beyond the validity period are strictly prohibited to use. 3.According to the needs of the operation, 1-5 cartridges can be used for the same operation, and the cartridges are individually packaged. 4.After removing the device, be sure to check the tissue bleeding after stapling. If there is bleeding, appropriate methods must be used to stop the bleeding. 5.When pushing the firing button for triggering, the force shall be uniform and the direction shall be kept straight; if the resistance is high during the triggering, do not use brute force to force the triggering. At this time, you need to open the free handle, reposition it, and then firing. If excessive force is applied during the triggering process or the direction of the force is deviated, it may cause the firing button to break off and affect the use of the device.

Primary placement in Germany; available across 2 countries total.

Trade name

Disposable Linear Cutter Staplers and Cartridges

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.

06954790930297

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-06954790930297

Reference / catalog number

TCYQ-80×3.85

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

—

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.

• H02020199LINEAR STAPLERS FOR OPEN SURGERY - OTHER

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.