FDA.reportPublic FDA data

Zutron Medical

Primary DI
00817658023837
Brand
Zutron Medical
Company
ZUTRON MEDICAL, L.L.C.
Model
Endo Leak Tester
Catalog number
ZUTR10005HH
Device description
Calibration Gauge for Endo-Leak Tester
Published
2023-09-21
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
FCYBulb, Inflation, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCYBulb, Inflation, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817658023837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817658023837008176580238378176580238370817658023837

GMDN Terms#

Term, Definition table
TermDefinition
Invasive medical device leak tester, electricalAn electrically-powered device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It typically incorporates an electric pump with a manometer and controls intended to be connected to the device tested. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8773435873xx@xx.xx

Regulatory Flags#

DUNS number
962532441
Device count
1
Premarket exempt
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
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
00817658020430Zutron MedicalEndoscopy Procedure KitZUTR400122023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995360191NAMEDIVATORS INC.FCY2026-02-04
00724995360207NAMEDIVATORS INC.FCY2026-02-04
00724995360214NAMEDIVATORS INC.FCY2026-02-04
00724995360221NAMEDIVATORS INC.FCY2026-02-04
00724995360238NAMEDIVATORS INC.FCY2026-02-04
00724995360245NAMEDIVATORS INC.FCY2026-02-04
00816185001127Dovideq LeakControl DeviceTorvan Medical IncFCY2025-09-18
00724995244415NAMEDIVATORS INC.FCY2025-06-10
00724995244422NAMEDIVATORS INC.FCY2025-06-10
00724995244439NAMEDIVATORS INC.FCY2025-06-10
00724995244446NAMEDIVATORS INC.FCY2025-06-10
00724995244453NAMEDIVATORS INC.FCY2025-06-10
00724995244460NAMEDIVATORS INC.FCY2025-06-10
00724995244477NAMEDIVATORS INC.FCY2025-06-10
00724995244484NAMEDIVATORS INC.FCY2025-06-10
00724995244491NAMEDIVATORS INC.FCY2025-06-10
50724995244410NAMEDIVATORS INC.FCY2025-06-10
50724995244427NAMEDIVATORS INC.FCY2025-06-10
50724995244434NAMEDIVATORS INC.FCY2025-06-10
50724995244441NAMEDIVATORS INC.FCY2025-06-10
50724995244458NAMEDIVATORS INC.FCY2025-06-10
50724995244465NAMEDIVATORS INC.FCY2025-06-10
50724995244472NAMEDIVATORS INC.FCY2025-06-10
50724995244489NAMEDIVATORS INC.FCY2025-06-10
50724995244496NAMEDIVATORS INC.FCY2025-06-10
00816185001141AutoSink with Endoscope Leak TesterTorvan Medical IncFCY2025-04-28
00816185001158LT Connector 1OTorvan Medical IncFCY2025-04-28
06971919462156noneNingbo Albert Novosino Co.,Ltd.FCY2025-03-14
04048551054901n.a.Karl Storz GmbH & Co. KGFCY2024-11-29
04055207070055NARichard Wolf GmbHFCY2024-06-03