Instrument Clamp 10
n/a - 8000-060-013
Device Description
A component of a surgical navigation and/or device tracking system (e.g., optical/electromagnetic device tracking system, computer-assisted neurosurgical ultrasound navigation system) intended to connect the system’s spatial marker [localizer/tracker/calibrator (e.g., infrared light reflector)] to a navigated surgical instrument (e.g., a stereotactic surgery system probe, dental drill), and/or to another marker; it may be affixed via dedicated screws. It is typically made of metallic or polymer materials and may be in the shape of a handle to facilitate handling the instrument during a procedure. This is a reusable device.
Environmental Conditions
- 106.00
- 80.00
- 75.00
- 30.00
- 30.00
- 10.00
- Keep Dry
- Keep away from Sunlight
- 50.00
- -10.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: HAW
Device Name: Neurological Stereotaxic Instrument
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 882.4560
Third Party Flag: N
Medical Specialty: NE
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: 07613327413151
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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