KIT 2120
Innervision, BioGlide® - 2120-925
Device Description
A collection of sterile devices intended to be used to implant an intracerebral ventricular catheter in a brain ventricle to function as a component of a ventriculo-peritoneal/atrial shunt for diversion of excessive cerebrospinal fluid (CSF) from the brain. The kit includes the catheter and a single-use rigid neuroscope intended for visual placement of the catheter; additional devices dedicated to catheter introduction/function (e.g., stylet) may be included.
Environmental Conditions
- Fragile
- Keep Dry
Device Sizes
- Angle: 0.0 degree
- Length: 15.5 Centimeter
- Outer Diameter: 1.1 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GWG
Device Name: Endoscope, Neurological
Device Class: 2
Physical State: N/A
Definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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: 882.1480
Third Party Flag: N
Medical Specialty: NE
Code: HCA
Device Name: Catheter, Ventricular
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: 882.4100
Third Party Flag: Y
Medical Specialty: NE
Device IdentifiersDevice Id: 00613994908476
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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