External Marker Cover B - MAJ-998
Device Description
A multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying three-dimensional (3-D) virtual images on a monitoring screen. The system primarily consists of a main control unit with monitor and an external EM field generator or sensor, and may also require/include an external reference sensor; additional accessories (e.g., remote control, stand/trolley) may also be included.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PGU
Device Name: Spatial Imaging For Display Of Endoscope Position
Device Class: 2
Physical State: A control unit that communicates with an endoscope/accessory probe, a receiver dish, and display monitor.
Definition: To detect and display the shape of an inserted endoscope.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Measures electromagnetic fields from the endoscope or an accessory within an endoscope to determine the shape of an inserted endoscope, and displays it on a monitor.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Gastrointestinal system
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Code: FDF
Device Name: Colonoscope And Accessories, Flexible/Rigid
Device Class: 2
Physical State: endoscope, accessories associated with colonoscope
Definition: To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Inserted into anus
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: colon or rectum
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device Identifiers
Device Id: 04953170077753
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
