Organization name

Micromedics, Inc.

SRN

US-MF-000018365

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• Use only with approved DuploSpray MIS Regulators. Connect regulator to regulated CO2 gas source; maximum input pressure not to exceed 100 psi (7 bar). See regulator IFU for more information. Caution must be used when applying product using pressurized gas. • Air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants. This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. When applying sealants using a spray device, be sure to use the flow rate recommended in the Instructions for Use. • To avoid possible gas embolism, do not spray directly into circulatory pathways. Any application of pressurized gas is associated with a potential risk of air embolism, tissue rupture or gas entrapment with compression, which may be life threatening. Be sure to take appropriate measures to address these risks by observing these recommendations: • Do not spray at a distance closer to the surface of tissues than 2 cm (3cm is recommended) at a maximum flow rate of 2.0 liters per minute (L/min). • When using pressurized spray devices, changes in blood pressure, pulse, oxygen saturations, and end tidal CO2 should be monitored because of the possibility of occurrence of air gas embolism.

  OTHER

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged

Primary placement in Belgium; available across 30 countries total.

Trade name

Spray Set 360 Endoscopic Applicator with Snap Lock

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.

20815634020607

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-20815634020607

Reference / catalog number

SA3768111

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

—

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.

• A020199SYRINGES, SINGLE-USE - OTHER

• Class IIa medical devices in EUDAMED

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