MAJ-1878 SCOPEGUIDE PROBE 2.8MM

MAJ
ENDOSCOPE POSITION MARKING PROBE - MAJ-1878

A long, flexible, invasive component of an electromagnetic (EM) endoscope tracking system intended for insertion into one of the channels (e.g., biopsy channel) of an appropriate in situ endoscope, and designed to emit EM pulses for locating/tracking the endoscope. It is intended to be used with endoscopes which do not have integrated EM pulse-generating tracking technology. The EM field/pulses generated by this device are received by external sensors. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• High-level Disinfectant
• Ethylene Oxide

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: FDA

Device Name: Enteroscope And Accessories

Device Class: 2

Physical State: enteroscope and related accessories, may include balloon, mini-scope

Definition: To provide visualization and perform various procedures within the small intestine. 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 through mouth or laparoscopically

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: small intestine

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 Id: 04953170353406

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