Organization name

MicroAire Surgical Instruments LLC

SRN

US-MF-000004063

Manufacturer status

Active

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

• Contraindication: Patients with chronic medical conditions, such as diabetes, heart, lung, or circulatory system disease.;Contraindication: For the treatment of obesity. ;Contraindication: Patients with severe skin laxity in the area of treatment.;Contraindication: Pregnant women.;Warning: Risk of infection from re-using single-use items. ;Warning: See IM-5020-CE Instruction Manual for detailed information on the 5020-CE Electric Instrument Console.;Warning: Use care to ensure that there is no electromagnetic interference between these devices and other devices in use. See IM-5020-CE for EMC information.;Warning: This device will not, in and of itself, produce significant weight reduction.;Warning: The volume of blood loss and endogenous fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety.;Warning: The use of electrosurgical equipment in close proximity to MicroAire instruments and instrument cables may cause malfunction.;Warning: Upon receipt and before each use, inspect the system and its components for visible damage. Do not use if there is apparent damage to any component. Failure to comply may result in healthcare professional and/or patient injury.;Warning: Large volume (over 5 L) aspiration may increase the risk of seroma, hematoma, and post-operative bleeding.;Warning: Darker pigmented patient population are at higher risk of hyperpigmentation. Create larger access incision than cannula to reduce friction that may cause hyperpigmentation.;Warning: Patients with poor skin elasticity are at risk of contour irregularities. Perform a pinch test and sweep test at various intervals throughout the procedure.

  OTHER

• After completing liposuction, routinely examine the areas visually as well as manually.;Warning: Single session liposuction extraction should not exceed 6,000 mL of supranatant fat.;Warning: History of previous deep vein thrombosis (DVT) should be considered when determining if a patient is a candidate for the procedure. DVT reoccurrence is possible.;Warning: If a device is involved in an adverse event/incident, contact MicroAire for evaluation and do not use the device on another patient;Warning: Reusable components must be cleaned and sterilized before every use, including first use.;Warning: Only use MicroAire Aspiration Tubing (REF PAL-1200). Using other tubing may result in tubing failure and unfavorable results.;Warning: Do not place Handpiece or Cable on the patient. Failure to comply may result in patient injury.;Warning: Universal precautions for handling contaminated materials should be observed at all times.;Warning: Cleaning of the Handpiece and Cable cannot be guaranteed if the allotted time between end-of-use and processing exceeds 30 minutes.;Warning: Failure to comply with maximum intended re-use may result in injury to patients.;Warning: Inspect devices after each use for defects. Discard if defects are found to avoid potential injury.;Warning: Sterilizers vary in design and performance parameters. Verify that the cycle parameters of the sterilizer meet the parameters outlined in the sterilization instructions contained in this IFU.;Warning: Do not modify equipment. Failure to comply may result in healthcare professional and/or patient injury.;Warning: PAL equipment can only be serviced by MicroAire or an Authorized MicroAire Repair Facility. DO NOT attempt to service the equipment. Unauthorized service will void the warranty.

  OTHER

Primary placement in Italy; available across 13 countries total.

Trade name

PAL Handpiece

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.

00847399018366

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.

08473990PALHANDV2

Reference / catalog number

PAL-650-CE

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

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://microaire.eifu.com/

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.

• Z12040214LIPOSUCTION SYSTEMS

• Class IIa medical devices in EUDAMED

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