FDA.reportPublic FDA data

Zutron Medical

Primary DI
00817658020959
Brand
Zutron Medical
Company
ZUTRON MEDICAL, L.L.C.
Model
Endoscopy Procedure Kit
Catalog number
ZUTR40030
Device description
Endoscopy Procedure Kit-Vented Bag, Transport Tote, Suction Tubing, Sponge
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

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
00817658020966PackageGS125Not in Commercial Distribution
00817658020959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817658020966008176580209668176580209660817658020966
00817658020959008176580209598176580209590817658020959

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.

Regulatory Flags#

DUNS number
962532441
Device count
1
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
10817658023216Zutron MedicalEndoscopy Procedure KitZUTR401112023-07-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956615533CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-26
10198956616585CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-26
10198956616639CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-26
10198956616752CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-26
10198956506572CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956595194CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956598553CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956613157CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956615397CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
06936603237397GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237403GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237410GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237427GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237434GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237441GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237458GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237465GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237489GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237496GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237502GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
10198956553903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956569331CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956595965CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956598355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956602236CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605442CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605497CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605640CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956607743CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609723CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19