Endochoice Drive Wire FSA-7501

GUDID 00817658020195

When added scope stiffness is desired to negotiate a difficult colon, and prior to re positioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual. These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes.

ZUTRON MEDICAL, L.L.C.

Colonoscope stiffener
Primary Device ID00817658020195
NIH Device Record Key1bce7ed0-6161-4bb9-9748-425729541b10
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndochoice Drive Wire
Version Model NumberFSA-7501
Catalog NumberFSA-7501
Company DUNS962532441
Company NameZUTRON MEDICAL, L.L.C.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817658020195 [Primary]

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-01

Devices Manufactured by ZUTRON MEDICAL, L.L.C.

00817658023783 - Zutron Medical2023-11-09 Endoscopy Procedure Kit includes Basin, Gauze, Suction Air Water Biopsy Valves, Auxiliary Water Connector, Fujifilm 700 Air Wate
00817658022687 - Zutron Medical2023-11-02 Multi-Enzymatic Foaming Cleanser RTU Spray Bottles
00817658021666 - Zutron Medical2023-09-29 Check valve, normally closed, non-sterile
00817658022007 - Zutron Medical2023-09-29 Endo-Leak Tester
00817658023790 - Zutron Medical2023-09-29 ACMI Leak Tester Adapter for Endo-Leak Tester
00817658023806 - Zutron Medical2023-09-29 Calibration Adapter Endo-Leak Tester
00817658023813 - Zutron Medical2023-09-29 Fujifilm Leak Tester Adapter for Endo-Leak Tester
00817658023820 - Zutron Medical2023-09-29 Fujifilm Leak Tester Adapter for Endo-Leak Tester (Coiled)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.