- Physicians Office Resource

12cm iQ Standard
Sonopet iQ - 550025S307

Device Description

A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

85.00
10.00

Handling Environment Temperature - Degrees Celsius

27.00
10.00

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

75.00
10.00

Storage Environment Temperature - Degrees Celsius

40.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LFL

Device Name: Instrument, Ultrasonic Surgical

Device Class: U

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 37613327422468

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327422467

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 07613327422467

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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