VIDEO SIGMOIDOSCOPES (REFURBISHED)
VIDEO SIGMOIDOSCOPE - ES-3830K
Device Description
An endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
- High-level Disinfectant
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: 04961333232635
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