DSD Edge Endoscope Reprocessing System

GUDID 00677964046674

MEDIVATORS INC.

Endoscope washer/disinfector
Primary Device ID00677964046674
NIH Device Record Key3cac28f8-0423-4543-91a6-ec04c4cb32f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDSD Edge Endoscope Reprocessing System
Version Model NumberDSD Edge 120V
Company DUNS068199363
Company NameMEDIVATORS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964046674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEBAccessories, Cleaning, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

Devices Manufactured by MEDIVATORS INC.

50677964151335 - Endo Carry-on Procedure Kit2025-08-25 Endo Carry-on Procedure Kit contains Basin, VIA Sponge, Defendo Fuji 700 5-Piece Kit, Absorbant Pad, Lubricant, Gauze, and DuoSw
50677964151342 - Endo Carry-on Procedure Kit2025-08-25 Endo Carry-on Procedure Kit contains Revital Ox Bedside Concentrate, Defendo Olympus 5-Piece Kit, Drawstring Pad, Absorbant Pads
50677964151359 - Endo Carry-on Procedure Kit2025-08-25 Endo Carry-on Procedure Kit contains Basin, VIA Enzymatic Sponge, Defendo Olympus 4-Piece Kit, Cleanascope Advantage Liners, Abs
50677964151366 - Endo Carry-on Procedure Kit2025-08-25 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-Piece Kit, Drawstring Pad, Extra Absorbant Pad, Lu
50677964151373 - Endo Carry-on Procedure Kit2025-08-25 Endo Carry-on Procedure Kit contains Basin, Defendo Olympus 5-Piece Kit, Transport Pad, Lubricant, Gauze, and Biohazard Sticker.
50677964151380 - Endo Carry-on Procedure Kit2025-08-25 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-Piece Kit, Take-Out Transport Pad, Lubricant, Gauz
50677964151397 - Endo Carry-on Procedure Kit2025-08-25 Endo Carry-on Procedure Kit contains Intercept Detergent Packet, Flat Sponge, Cylindrical Sponge, STERIS Fuji 700 4-Piece Kit, D
50677964151403 - Endo Carry-on Procedure Kit2025-08-25 Endo Carry-on Procedure Kit contains Intercept Bedside Complete Kit, Defendo Olympus 5-Piece Kit, Drawstring Pad, Lubricant, Gau

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.