PROFESS(TM) REGISTRATION KIT
PROFESS - 6001-420-000
Device Description
A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.
Environmental Conditions
- 106.00
- 70.00
- 75.00
- 30.00
- 40.00
- 10.00
- 5V
- TRANSPORT:10-90%/-20-50¿C/50-106KPA
- 106.00
- 50.00
- 85.00
- 30.00
- 35.00
- 4.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PGW
Device Name: Ear, Nose, And Throat Stereotaxic Instrument
Device Class: 2
Physical State: Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer.
Definition: Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Submission Type ID: 1
Review Panel: EN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Ear, nose and throat
Regulation Number: 882.4560
Third Party Flag: N
Medical Specialty: NE
Device IdentifiersDevice Id: 07613252727057
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