MAJ-1868 ScopeGuide Receiver Dish

MAJ
RECIVER DISH - MAJ-1868

An external, electrically-powered component of a gastrointestinal catheter/endoscope tracking system designed to receive and process electromagnetic (EM) field data produced by an appropriate catheter/endoscope in situ for real-time visualization of the catheter/endoscope position within the gastrointestinal tract. It is typically a flat panel designed to be mounted next to the patient to transcutaneously receive the specific EM pulses generated by the catheter/endoscope and transmit the data to an appropriate processing unit/monitor (not included).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 04953170305689

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