| Primary Device ID | 00817658020188 |
| NIH Device Record Key | 8a5efee5-d1c7-4a08-8ee3-df7a7adca808 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zutron Medical |
| Version Model Number | ZUTR162000 |
| Catalog Number | ZUTR162000 |
| Company DUNS | 962532441 |
| Company Name | ZUTRON MEDICAL, L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817658020188 [Primary] |
| FDF | Colonoscope And Accessories, Flexible/Rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
[00817658020188]
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-12-01 |
| 00817658020188 | The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and |
| 00817658020164 | When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning |
| 00817658020157 | When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning |
| 00817658020010 | CONTENTS: Endoscopy Kit - Lube Jelly (2) - Gauze (10) - Suction Tubing (10') - Cleaning Brush - |
| 00817658023356 | Endoscopy Procedure Kit (Bulk)-Basin, Gauze, Lube, Sponge, Check Valve, Vent Bag |
| 00817658023318 | Endoscopy Procedure Kit (Bulk)-Sponge, Scope Tip Protector, Biopsy Port Cap, Vented Bag |
| 00817658023288 | Endoscopy Kit- Biopsy Valve, Toothbrush, Sponge, Scope Tip Protector, Check Valve, Vented Bag |
| 00817658023219 | Endoscopy Procedure Kit (Bulk)- Channel Cleaning Brush with Valve, Air/Water Suction Biopsy Val |
| 00817658023769 | Endoscopy Kit-Basin with Lid, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Wate |
| 00817658023745 | Endoscopy Kit-Basin with Lid, Transport Tote, Suction Tubing, Valve Brush, Channel Cleaning Brus |
| 00817658023721 | Endoscopy Kit-Basin, Channel Brushes, Gauze, Lube, Transport Tote, Scope Tip Protector, Suction |
| 00817658023691 | Endoscopy Kit-Basin, Gauze, Sponges, Lube, Valve Bag, Channel Brush, Scope Tip Protector, Transp |
| 00817658023677 | Endoscopy Procedure Kit-Sponges, Basin, Vented Bag, Transport Tote, Channel Cleaning Brush, Lube |
| 00817658023653 | Endoscopy Combo Kit-Vented Bags, Basin, Channel Cleaning Brush with Valve Brush, Gauze, Sponge, |
| 00817658023639 | Endoscopy Procedure Kit-Basin, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Wat |
| 00817658023592 | Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Spon |
| 00817658023554 | Bedside Kit-Basin, Gauze, Sponges, Port Cover, Lube, Suction Tubing |
| 00817658023530 | Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Fujifilm Cl |
| 00817658023479 | Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, |
| 00817658023455 | Endoscopy Combo Kit-Basin with Lid, Sponges, Transport Tote, Channel Cleaning Brush with Valve B |
| 00817658023417 | Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Spong |
| 00817658023394 | Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, |
| 00817658023370 | Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, |
| 00817658023349 | Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Fujifilm Cle |
| 00817658023301 | Endoscopy Combo Kit-Basin, Gauze, Sponges, Biopsy Valve, Lube, Vent Bags, Channel Cleaning Brush |
| 00817658023271 | Endoscopy Combo Kit-Basin, Gauze, Sponges, Lube, Transport Tote, Underpad, Suction Tubing with S |
| 00817658023257 | Endoscopy Procedure Kit-Basin, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Wat |
| 00817658023233 | Endoscopy Procedure Kit-Basin, Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Basin Lid, Trans |
| 00817658023202 | Endoscopy Procedure Kit-Basin, Gauze, Sponges, Lube, Sterile Check Valve, Biopsy Port Cap, Trans |
| 00817658023189 | Endoscopy Combo Kit-Basin, Biopsy Valve, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush |
| 00817658023158 | Endoscopy Combo Kit- Basin, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve B |
| 00817658023134 | Endoscopy Procedure Kit-Basin, Gauze, Sponges, Lube, Air/Water Suction Biopsy Valves and Auxilia |
| 00817658023110 | Endoscopy Combo Kit-Basin with Lid, Olympus 4- Pack, Gauze, Sponges, Lube, Transport Tote, Sucti |
| 00817658023080 | Endoscopy Kit-Sponges, Zzyme, Scope Tip Protector, Valve Purse, Vented Bag |
| 00817658023066 | Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Spong |
| 00817658023042 | Endoscopy Procedure Kit-Basin with Lid, Gauze, Sponge, Lube, Air/Water Suction Biopsy Valves and |
| 00817658023028 | Endoscopy Combo Kit-Basin, Fujifilm Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Channel Cle |
| 00817658023004 | Endoscopy Procedure Kit-Basin with Lid, Sponges, Port Cap, Transport Tote, Channel/ Valve Brush, |
| 00817658022984 | Endoscopy Procedure Kit-Basin, Biopsy Valve, Check Valve, Gauze, Sponges, Lube, Vent Bags, Chann |
| 00817658023684 | Endoscopy Kit-Basin with Lid, Fujifilm Connector, Air/Water Suction Biopsy Valves and Auxiliary |
| 00817658022915 | Endoscopy Procedure Kit-Basin, Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Transport Tote, |
| 00817658022892 | Endoscopy Procedure Kit-Basin, Check Valve, Sponges, Channel Cleaning Brush, Vent Bag |
| 00817658022861 | Endoscopy Kit-Sponge, Air/Water Suction Biopsy Valves and Auxiliary Water, Scope Tip Protector, |
| 00817658022823 | Endoscopy Kit-Gauze, Sponge, Lube, Olympus 4 Pack, Channel Cleaning Brush, Vented Bag |
| 00817658022762 | Endoscopy Procedure Kit-Basin with Lid, Check Valve Brush, Vented Bag, Syringe, Sponge, Scope Ta |
| 00817658022441 | Endoscopy Kit-Basin, Biopsy Valve, Check Valve, Gauze, Sponges, Lube, Vent Bags, Channel Cleanin |
| 00817658022403 | Endoscopy Combo Kit-Bag, Gauze, Sponges, Lube, Fujifilm, Transport Tote, Channel Cleaning Brushe |
| 00817658022281 | Endoscopy Procedure Kit-Basin, Fujifilm, Gauze, Sponges, Lube, Transport Tote, Suction Tubing, U |
| 00817658022250 | Endoscopy Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, |
| 00817658022182 | Endoscopy Kit-Sponges, Zzyme, Scope Tip Protector, Wipes, Vented Bag |