AccessGUDID - DEVICE: Saneso (G347SBA0)

GUDID

Device Identifier (DI) Information

Brand Name: Saneso
Version or Model: G347SBA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Saneso Inc.

Primary DI Number: G347SBA0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117059270 *Terms of Use

Device Description: The Saneso Box incorporates state of the art electronics and software and is the brain behind Saneso’s endoscopy system. It executes all technological innovations incorporated in the Saneso colonoscope and gastroscope.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47140	Endoscopic control/video-imaging system	A mains electricity (AC-powered) multifunctional device assembly designed to interface with a flexible steerable, self-propelled, or externally-propelled video endoscope (not included) to: 1) control movement of the endoscope (e.g., steer, propel); and 2) receive and process electronic video image signals sent from the endoscope. It includes a controller/control unit, image processor, and may include an image display monitor and light source. It might additionally allow control of insufflation or suction.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210052	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c4dfd693-51f9-45eb-ba3b-1d5c31869640
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 11, 2022