Disposable Endo Cutter and Cartridges

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 endo 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 endo 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.The maximum number of firing of the stapler is 8 times. In the same operation, replaceable reloads, and it can be fired continuously for 8 times. Reload shall not be replaced more than the maximum number of percussion. The use of stapler in conjunction with anastomotic line reinforcement materials may reduce the number of percussion. 4.During abdominal surgery, if a proper pneumoperitoneum cannot be formed and maintained, it may reduce the available operating space and increase the risk of visceral tissue injury. 5.MRI magnetic resonance compatibility and limited use conditions: The staple is made of pure titanium material, which is not affected by MRI magnetic resonance interference. 6.Type Ⅱ stapler: Before reinstalling the reload, the used stapler is rinsed with sterile solution and wiped against the anvil and the jaws of the cartridges to remove all the formed but unused staples from the device. The instrument can only be used after no staple in the anvil and the jaw of the cartridge is confirmed through visual inspection. 7.This instruction for use is only a general introduction to the use of the stapler, and is not for surgical guidance. The surgeon must refer to the relevant medical literature and related surgical atlas during the operation.

Primary placement in Germany; available across 1 country total.

Trade name

Disposable Endo Cutter 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.

06954790915799

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-06954790915799

Reference / catalog number

TCZNZO-30F

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.

• H02030199LINEAR STAPLERS FOR VIDEOSURGERY - OTHER
• H02020199LINEAR STAPLERS FOR OPEN SURGERY - OTHER

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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