xx.xxZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
ZUTRON MEDICAL LLC
ZUTRON MEDICAL LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005299806 | 3005299806 | ZUTRON MEDICAL LLC | 1 | N | 2020-04-25 | 17501 w 98th street #40-27 Lenexa KS US 66219 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00817658023790 | Zutron Medical - ACMI Leak Tester Adapter for Endo-Leak Tester | 8773435873 | xx@xx.xx |
| 00817658023806 | Zutron Medical - Calibration Adapter Endo-Leak Tester | 8773435873 | xx@xx.xx |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 65577 | 1040567220 | K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE | OCX | 2015-03-10 |
| 65577 | 1110267182 | K093718 | ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 | FCY | 2010-02-22 |
| 65577 | 1813108285 | K051068 | ZUTRON COLONOSCOPE STIFFENING DEVICE | FDF | 2005-07-11 |
| 65577 | 1032998681 | ||||
| 65577 | 1108970750 | ||||
| 65577 | 1116153414 | ||||
| 65577 | 1280443379 | ||||
| 65577 | 1515403958 | ||||
| 65577 | 1812849516 | ||||
| 65577 | 2053030621 |
Product Codes Associated With Registrations#
PMN#
ZUTRON COLONOSCOPE STIFFENING DEVICE
ZUTRON MEDICAL
GUDID#
Zutron Medical - Wolf Leak Tester Adapter for Endo-Leak Tester
2023-09-21
Zutron Medical - Storz Leak Tester Adapter for Endo-Leak Tester
2023-09-21
Zutron Medical - Pentax Leak Tester Adapter for Endo-Leak Tester
2023-09-21
Zutron Medical - Olympus Leak Tester Adapter for Endo-Leak Tester
2023-09-21
Zutron Medical - Calibration Gauge for Endo-Leak Tester
2023-09-21
Zutron Medical - Fujifilm Leak Tester Adapter for Endo-Leak Tester
2023-09-21
Zutron Medical - Calibration Adapter Endo-Leak Tester
2023-09-21
Zutron Medical - ACMI Leak Tester Adapter for Endo-Leak Tester
2023-09-21
Zutron Medical - Endo-Leak Tester
2023-09-21
Endochoice Drive Wire - 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 The device is then withdrawn and the procedure is completed as usual.These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes.
2016-12-01
Zutron Medical - The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope StiffeningDevice.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes.
2016-12-01
Zutron Medical - When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning 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.
2016-12-01
Zutron Medical - When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning 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.
2016-12-01
Zutron Medical - Endoscopy Kit-Basin, Gauze, Sponges, Lube, Valve Bag, Channel Brush, Scope Tip Protector, Transport Tote, Suction Tubing
2023-07-28
Zutron Medical - Olympus ETO Alignment Wrench
2023-09-21
Zutron Medical - Endoscopy Procedure Kit includes Basin, Gauze, Suction Air Water Biopsy Valves, Auxiliary Water Connector, Fujifilm 700 Air Water Cleaning Valve, Lube, Channel Brush, Flat Sponge with Enzymatic Cleaner and General Brush, Toothbrush Style.
2023-11-01
Zutron Medical - Endoscopy Kit-Basin with Lid, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Water, Cleaning Valve Brush, Lube, Scope Tip, Protector
2023-07-28
Zutron Medical - Endoscopy Kit-Basin with Lid, Transport Tote, Suction Tubing, Valve Brush, Channel Cleaning Brush, Sponge, Vent Bag
2023-07-28
Zutron Medical - Endoscopy Kit-Basin, Channel Brushes, Gauze, Lube, Transport Tote, Scope Tip Protector, Suction Tubing, Vented Bag
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Sponges, Basin, Vented Bag, Transport Tote, Channel Cleaning Brush, Lube, Biopsy Valve, Gauze, Check Valve Brush
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Vented Bags, Basin, Channel Cleaning Brush with Valve Brush, Gauze, Sponge, Lube, Scope Tip Protector, Valve Net
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Water, Lube, Vented Bag, Transport Tote, Channel Cleaning Brush with Valve Brush
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, Transport Tote, Suction Tubing, Syringe
2023-07-28
Zutron Medical - Bedside Kit-Basin, Gauze, Sponges, Port Cover, Lube, Suction Tubing
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Fujifilm Cleaning Adapter, Gauze, Sponges, Lube, Transport Tote, Suction Tubing, Syringe, Vented Bag
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, Transport Tote, Suction Tubing, Channel Cleaning Brush with Valve Brush, Scope Tip Protector, Vent Bag
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Basin with Lid, Sponges, Transport Tote, Channel Cleaning Brush with Valve Brush, Endoscope Tip Protector, Vent Bag
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Transport Tote, Channel Cleaning Brush, Vent Bag
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve Brush, Scope Tip Protector, Vented Bag, Transport Tote, Suction Tubing with Scallop Connectors
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush, Valve Brush, Scope Tip Protector, Vented Bag, Transport Tote, Suction Tubing with Scallop Connectors
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Fujifilm Cleaning Adapter, Gauze, Sponges, Lube, Transport Tote, Suction Tubing with Scallop Connectors, Syringe, Vented Bag
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Basin, Gauze, Sponges, Biopsy Valve, Lube, Vent Bags, Channel Cleaning Brush with Valve Brush, Scope Tip Protector, Valve Net, Suction Tubing
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Basin, Gauze, Sponges, Lube, Transport Tote, Underpad, Suction Tubing with Scallop Connectors, Vented Bag
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Water, Channel Cleaning Brush, Suction Tubing, Vent Bag
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Basin Lid, Transport Tote, Suction Tubing with Scallop Connectors, Valve Net, Scope Tip Protector, Scope Tag, Valve Brush, Channel Cleaning Brush, Vent Bag
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Gauze, Sponges, Lube, Sterile Check Valve, Biopsy Port Cap, Transport Tote, Channel Cleaning Brush with Valve Brush, Vent Bag
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Basin, Biopsy Valve, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve Brush, Transport Tote, Valve Net, Scope Tip Protector
2023-07-28
Zutron Medical - Endoscopy Combo Kit- Basin, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve Brush, Scope Tip Protector, Valve Net, Vent Bag
2023-07-28
Zutron Medical - Endoscopy Procedure Kit-Basin, Gauze, Sponges, Lube, Air/Water Suction Biopsy Valves and Auxiliary Water, Vent Bags, Channel Cleaning Brush with Valve Brush, Transport Tote, Syringe
2023-07-28
Zutron Medical - Endoscopy Combo Kit-Basin with Lid, Olympus 4- Pack, Gauze, Sponges, Lube, Transport Tote, Suction Tubing, Channel Cleaning Brush, Scope Tip Protector, Vent Bag
2023-07-28