EM Stylet
N/A - 8900-200-200
Device Description
A sterile, invasive, flexible wire with an electromagnetic (EM) coil transmitter at the distal end designed to be inserted into an intracranial catheter to help guide the surgical insertion of the catheter through the skull for placement in the brain. It is proximally connected to a line-powered EM neurosurgical navigation system which tracks and displays the position of the stylet for precise navigation during the procedure. This is a single-use device.
Environmental Conditions
- 106.00
- 70.00
- 75.00
- 30.00
- 30.00
- 10.00
- Fragile, Handle with Care
- Transport humidity, 90, 10, Relative Humidity
- Transport temperature, 50, -10, Degrees Celsius
- Transport atmospheric pressure, 106, 70, Kilo Pascal
- Keep Dry
- 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: 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 IdentifiersDevice Id: 37613327499712
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613327499711
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 07613327499711
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