FDA.reportPublic FDA data

Zutron Medical

Primary DI
00817658020188
Brand
Zutron Medical
Company
ZUTRON MEDICAL, L.L.C.
Model
ZUTR162000
Catalog number
ZUTR162000
Device description
The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope StiffeningDevice.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes.
Published
2016-12-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817658020188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817658020188008176580201888176580201880817658020188

GMDN Terms#

Term, Definition table
TermDefinition
Colonoscope stiffenerA dedicated stiff wire that is inserted into a flexible colonoscope to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required during a colonoscopy. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

Regulatory Flags#

DUNS number
962532441
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
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