DISPOSABLE DISTAL ATTACHMENT

DISPOSABLE DISTAL ATTACHMENT - D-201-15004

A short, light-penetrating tube designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap and is available in a range of diameters to accommodate common endoscope diameters. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: FDS

Device Name: Gastroscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with gastroscope

Definition: To examine or perform procedures in the stomach. 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 orally into the stomach

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: stomach

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170453905

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170453908

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170453908

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