FLUOROSCOPY TRACKER KIT, 12''

FLUOROSCOPY TRACKER KIT, 12''
NA - 6004-512-000

Device Description

An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

85.00
25.00

Handling Environment Temperature - Degrees Celsius

30.00
10.00

Special Storage Condition, Specify

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

Diameter: 12.0 Inch

Diameter: 12.0 Inch

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Device Identifiers

Device Id: 04546540401090

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