SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ (REFURBISHED)
ENTEROSCOPE - VSB-3430K
Device Description
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (duodenum, jejunum, and ileum). It is inserted into the body through the mouth or the anus during enteroscopy typically to examine strictures, assess Crohn's's disease, or take biopsies. It may be designed to be manually inserted or may be designed with features to assist/power insertion (e.g., push/pull double-balloons, powered spiralling motor). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. 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: 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 IdentifiersDevice Id: 04961333232925
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