Zutron Medical ZUTR50523

GUDID 00817658021666

Check valve, normally closed, non-sterile

ZUTRON MEDICAL, L.L.C.

Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use
Primary Device ID00817658021666
NIH Device Record Keybb8c4c11-b9d4-4751-a652-d584101c9e5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameZutron Medical
Version Model NumberZUTR50523
Catalog NumberZUTR50523
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx
Phone8773435873
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100817658021659 [Primary]
GS100817658021666 [Package]
Contains: 00817658021659
Package: Case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-29
Device Publish Date2023-09-21

On-Brand Devices [Zutron Medical]

00817658020188The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and
00817658020164When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning
00817658020157When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning
00817658020010CONTENTS: Endoscopy Kit - Lube Jelly (2) - Gauze (10) - Suction Tubing (10') - Cleaning Brush -
00817658023356Endoscopy Procedure Kit (Bulk)-Basin, Gauze, Lube, Sponge, Check Valve, Vent Bag
00817658023318Endoscopy Procedure Kit (Bulk)-Sponge, Scope Tip Protector, Biopsy Port Cap, Vented Bag
00817658023288Endoscopy Kit- Biopsy Valve, Toothbrush, Sponge, Scope Tip Protector, Check Valve, Vented Bag
00817658023219Endoscopy Procedure Kit (Bulk)- Channel Cleaning Brush with Valve, Air/Water Suction Biopsy Val
00817658023769Endoscopy Kit-Basin with Lid, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Wate
00817658023745Endoscopy Kit-Basin with Lid, Transport Tote, Suction Tubing, Valve Brush, Channel Cleaning Brus
00817658023721Endoscopy Kit-Basin, Channel Brushes, Gauze, Lube, Transport Tote, Scope Tip Protector, Suction
00817658023691Endoscopy Kit-Basin, Gauze, Sponges, Lube, Valve Bag, Channel Brush, Scope Tip Protector, Transp
00817658023677Endoscopy Procedure Kit-Sponges, Basin, Vented Bag, Transport Tote, Channel Cleaning Brush, Lube
00817658023653Endoscopy Combo Kit-Vented Bags, Basin, Channel Cleaning Brush with Valve Brush, Gauze, Sponge,
00817658023639Endoscopy Procedure Kit-Basin, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Wat
00817658023592Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Spon
00817658023554Bedside Kit-Basin, Gauze, Sponges, Port Cover, Lube, Suction Tubing
00817658023530Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Fujifilm Cl
00817658023479Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges,
00817658023455Endoscopy Combo Kit-Basin with Lid, Sponges, Transport Tote, Channel Cleaning Brush with Valve B
00817658023417Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Spong
00817658023394Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges,
00817658023370Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges,
00817658023349Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Fujifilm Cle
00817658023301Endoscopy Combo Kit-Basin, Gauze, Sponges, Biopsy Valve, Lube, Vent Bags, Channel Cleaning Brush
00817658023271Endoscopy Combo Kit-Basin, Gauze, Sponges, Lube, Transport Tote, Underpad, Suction Tubing with S
00817658023257Endoscopy Procedure Kit-Basin, Gauze, Sponges, Air/Water Suction Biopsy Valves and Auxiliary Wat
00817658023233Endoscopy Procedure Kit-Basin, Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Basin Lid, Trans
00817658023202Endoscopy Procedure Kit-Basin, Gauze, Sponges, Lube, Sterile Check Valve, Biopsy Port Cap, Trans
00817658023189Endoscopy Combo Kit-Basin, Biopsy Valve, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush
00817658023158Endoscopy Combo Kit- Basin, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve B
00817658023134Endoscopy Procedure Kit-Basin, Gauze, Sponges, Lube, Air/Water Suction Biopsy Valves and Auxilia
00817658023110Endoscopy Combo Kit-Basin with Lid, Olympus 4- Pack, Gauze, Sponges, Lube, Transport Tote, Sucti
00817658023080Endoscopy Kit-Sponges, Zzyme, Scope Tip Protector, Valve Purse, Vented Bag
00817658023066Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Spong
00817658023042Endoscopy Procedure Kit-Basin with Lid, Gauze, Sponge, Lube, Air/Water Suction Biopsy Valves and
00817658023028Endoscopy Combo Kit-Basin, Fujifilm Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Channel Cle
00817658023004Endoscopy Procedure Kit-Basin with Lid, Sponges, Port Cap, Transport Tote, Channel/ Valve Brush,
00817658022984Endoscopy Procedure Kit-Basin, Biopsy Valve, Check Valve, Gauze, Sponges, Lube, Vent Bags, Chann
00817658023684Endoscopy Kit-Basin with Lid, Fujifilm Connector, Air/Water Suction Biopsy Valves and Auxiliary
00817658022915Endoscopy Procedure Kit-Basin, Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Transport Tote,
00817658022892Endoscopy Procedure Kit-Basin, Check Valve, Sponges, Channel Cleaning Brush, Vent Bag
00817658022861Endoscopy Kit-Sponge, Air/Water Suction Biopsy Valves and Auxiliary Water, Scope Tip Protector,
00817658022823Endoscopy Kit-Gauze, Sponge, Lube, Olympus 4 Pack, Channel Cleaning Brush, Vented Bag
00817658022762Endoscopy Procedure Kit-Basin with Lid, Check Valve Brush, Vented Bag, Syringe, Sponge, Scope Ta
00817658022441Endoscopy Kit-Basin, Biopsy Valve, Check Valve, Gauze, Sponges, Lube, Vent Bags, Channel Cleanin
00817658022403Endoscopy Combo Kit-Bag, Gauze, Sponges, Lube, Fujifilm, Transport Tote, Channel Cleaning Brushe
00817658022281Endoscopy Procedure Kit-Basin, Fujifilm, Gauze, Sponges, Lube, Transport Tote, Suction Tubing, U
00817658022250Endoscopy Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube,
00817658022182Endoscopy Kit-Sponges, Zzyme, Scope Tip Protector, Wipes, Vented Bag
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