Welch Allyn 6.0 V Illumination System for Disposable Endoscopes; Insufflation Bulb (#30200), Fiber
Welch Allyn, Inc. - 901074
Device Description
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, or polyps. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FAM
Device Name: Sigmoidoscope And Accessories, Flexible/Rigid
Device Class: 2
Physical State: endoscope, accessories associated with sigmoidoscope
Definition: to examine and perform procedures within the sigmoid (descending) colon
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: instrument guided through rectum into the large intestine
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: sigmoid (descending) colon
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 00732094080384
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