EUDAMED last updated this device on Aug 5, 2023

GENERAL OPERATING SCISSORS

B-G11804OS121170

On the marketClass IIa

Applicable legislation: —
Organization name: Surgicrafts
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: G11804OS121170
Reference / catalog number: 04OS-121-17

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

GENERAL OPERATING SCISSORS is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Surgicrafts. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: GENERAL OPERATING SCISSORS
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: G11804OS121170
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. View in glossary →: B-G11804OS121170
Reference / catalog number: 04OS-121-17
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device. [EN]
Additional information URL: https://surgicrafts.com/product/operating-scissors-11-5cm-b-b-str/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

G11804OS121170

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

K01020102MINIMALLY INVASIVE SURGERY SCISSORS, SINGLE-USE

Critical warnings

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

Do not re-use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Belgium; available across 8 countries total.

Country	On market since	Until
BelgiumPrimary placement	—	Still on market
Cyprus	—	Still on market
Germany	—	Still on market
Spain	—	Still on market
Poland	—	Still on market
Slovakia	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: GENERAL OPERATING SCISSORS
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: G11804OS121170
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. View in glossary →: B-G11804OS121170
Reference / catalog number: 04OS-121-17
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Device details

Quantity: 1
Additional product description: A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device. [EN]
Additional information URL: https://surgicrafts.com/product/operating-scissors-11-5cm-b-b-str/
Clinical sizes: No clinical sizes registered for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Belgium; available across 8 countries total.

Country	On market since	Until
BelgiumPrimary placement	—	Still on market
Cyprus	—	Still on market
Germany	—	Still on market
Spain	—	Still on market
Poland	—	Still on market
Slovakia	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

GENERAL OPERATING SCISSORS

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

Related devices

Certificates