FDA.reportPublic FDA data

Zutron Medical

Primary DI
00817658023271
Brand
Zutron Medical
Company
ZUTRON MEDICAL, L.L.C.
Model
Endoscopy Procedure Kit
Catalog number
ZUTR40113
Device description
Endoscopy Combo Kit-Basin, Gauze, Sponges, Lube, Transport Tote, Underpad, Suction Tubing with Scallop Connectors, Vented Bag
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00817658023271PackageGS125In Commercial Distribution
00817658023264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817658023271008176580232718176580232710817658023271
00817658023264008176580232648176580232640817658023264

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8773435873xx@xx.xx

Regulatory Flags#

DUNS number
962532441
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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