FDA.reportPublic FDA data

VIA procedure kit - custom

Primary DI
00816765014752
Brand
VIA procedure kit - custom
Company
US Endoscopy
Model
00717094
Catalog number
00717094
Device description
The VIA Procedure Kit - custom includes transport pad, gauze, solidifier, basin, enzymatic sponge, lubricating jelly, tubing, syringe, BioGuard air/water and suction valves, BioShield valve, and Torrent scope connector-Olympus.
Published
2018-07-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10724995181830PackageGS112In Commercial Distribution
10816765014759PackageGS112Not in Commercial Distribution
00816765014752PreviousGS10
00724995181833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518183010724995181830
1081676501475910816765014759
00816765014752008167650147528167650147520816765014752
00724995181833007249951818337249951818330724995181833

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
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956495067CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
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10198956528963CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956457768CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
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10198956486065CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
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10198956508286CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956512382CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
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10198956528260CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
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10198956525061CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
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10198956364349CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
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10198956474673CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
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10198956489684CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
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