AccessGUDID - DEVICE: DSD Edge Endoscope Reprocessing System (00677964046674)

GUDID

Device Identifier (DI) Information

Brand Name: DSD Edge Endoscope Reprocessing System
Version or Model: DSD Edge 120V
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DSD3008
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964046674
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: DSD Edge Endoscope Reprocessing System

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?
66649	Endoscope washer-disinfector (chemical)	An electrically-powered unit intended to be used for both washing and chemical disinfection of endoscopes, and their accessories. It has built-in features to circulate cleaning and disinfectant solutions through the lumen (flushing) of the endoscope; some types may also have built-in drying features. It is not intended for device sterilization.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEB	Accessories, Cleaning, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092387	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: 3cac28f8-0423-4543-91a6-ec04c4cb32f1
Public Version Date: February 27, 2023
Public Version Number: 6
DI Record Publish Date: September 16, 2016