MAJ-1860 ScopeGuide Reference Plate

MAJ
REFERENCE PLATE - MAJ-1860

An external component of an electromagnetic (EM) endoscope tracking system designed to emit EM pulses for spatial referencing of an appropriate EM pulse-transmitting endoscope in situ. It is intended to be attached to, or held next to, the patient; the system sensor (not included) simultaneously receives signals from both the endoscope and the reference transmitter for spatial referencing. This is a reusable device.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• High-level Disinfectant

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: 04953170305672

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