FDA.reportPublic FDA data

Zutron Medical

Primary DI
10817658023216
Brand
Zutron Medical
Company
ZUTRON MEDICAL, L.L.C.
Model
Endoscopy Procedure Kit
Catalog number
ZUTR40111
Device description
Endoscopy Procedure Kit (Bulk)- Channel Cleaning Brush with Valve, Air/Water Suction Biopsy Valves and Auxiliary Water, Scope Tip Protector, Vented Bag
Published
2023-07-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWUEndoscope Introducer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817658023216PrimaryGS10
00817658023219Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081765802321610817658023216
00817658023219008176580232198176580232190817658023219

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopy preparation kitA collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8773435873xx@xx.xx

Regulatory Flags#

DUNS number
962532441
Device count
50
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817658022007Zutron MedicalEndo Leak TesterZUTR300052023-09-21
00817658023790Zutron MedicalEndo Leak TesterZUTR10005A2023-09-21
00817658023806Zutron MedicalEndo Leak TesterZUTR10005CA2023-09-21
00817658023813Zutron MedicalEndo Leak TesterZUTR10005F2023-09-21
00817658023837Zutron MedicalEndo Leak TesterZUTR10005HH2023-09-21
00817658023844Zutron MedicalEndo Leak TesterZUTR10005O2023-09-21
00817658023868Zutron MedicalEndo Leak TesterZUTR10005P2023-09-21
00817658023875Zutron MedicalEndo Leak TesterZUTR10005S2023-09-21
00817658023882Zutron MedicalEndo Leak TesterZUTR10005W2023-09-21
10817658023285Zutron MedicalEndoscopy Procedure KitZUTRMNGI2023-07-28
10817658023315Zutron MedicalEndoscopy Procedure KitZUTR401162023-07-28
10817658023353Zutron MedicalEndoscopy Procedure KitZUTR401232023-07-28
00817658020003Zutron MedicalEndoscopy Procedure KitZUTR400012016-12-01
00817658020072Zutron MedicalEndoscopy Procedure KitZUTR400032023-07-28
00817658020102Zutron MedicalEndoscopy Procedure KitZUTR40004 2023-07-28
00817658020133Zutron MedicalEndoscopy Procedure KitZUTR400082023-07-28
00817658020270Zutron MedicalEndoscopy Procedure KitZUTR401032023-07-28
00817658020348Zutron MedicalEndoscopy Procedure KitZUTR40008DBL2023-07-28
00817658020409Zutron MedicalEndoscopy Procedure KitZUTR400112023-07-28
00817658020430Zutron MedicalEndoscopy Procedure KitZUTR400122023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528358HALYARDAVID MEDICAL, INC.NWU2026-08-01
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10198956497740CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956501881CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956509511CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956519657CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956537132CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539174CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539891CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956346567CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956373945CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956404960CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956439894CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956454224CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956498334CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956498402CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956513037CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956514621CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956518506CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519428CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956520127CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956521179CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956523531CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956530942CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531338CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531765CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532571CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532649CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956534056CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27