SINGLE USE DISTAL COVER MAJ-2315

SINGLE USE DISTAL COVER MAJ
SINGLE USE DISTAL COVER - MAJ-2315

An invasive device, typically in the form of a detachable cap, designed to cover the exposed mechanical components at the distal end of an endoscope (e.g., duodenoscope) during an endoscopic procedure to protect the patient from injury. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NWB

Device Name: Endoscope, Accessories, Narrow Band Spectrum

Device Class: 2

Physical State: The system consists of flexible and/or ridgid scope(s), light source(s), video processor and display

Definition: Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Enhances visualization of specific structures and reduces obscuring effects by using narrow bands of the visible spectrum for illumination. Narrow band illumination is accomplished through the modification of broadband light sources with optical filters or using light sources with inherently limited spectra such as lasers

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Limited to endoscopic systems for observation of the gastro-urological tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: FDT

Device Name: Duodenoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with duodenoscope

Definition: To examine the duodenum and to perform various procedures within the duodenum. 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: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted orally into duodenum

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: duodenum, esophagus

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170403016

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170403019

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170403019

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

Device Id: 54953170403014

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 14953170403016

Package Quantity: 60

Package Discontinue Date: 9/19/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A