FDA.reportPublic FDA data

VIA

Primary DI
10816765014421
Brand
VIA
Company
US Endoscopy
Model
00717068
Catalog number
00717068
Device description
The VIA Procedure Kit - custom includes gauze pads, biohazard sticker, basin, enzymatic sponge, lubricating jelly, gown, Double Header cleaning brush, BioGuard air water and suction valves, and BioShield biopsy valve.
Published
2018-04-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10816765014421PackageGS112Not in Commercial Distribution
00816765014424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501442110816765014421
00816765014424008167650144248167650144240816765014424

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
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570733CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-30
10198956396906CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956552548CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568419CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568518CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956574564CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956590526CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956593824CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956594074CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956595903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956388239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956531697CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956568372CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956576759CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956587328CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956589131CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956590151CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956590489CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956590618CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956593138CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956554283CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956557000CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956557390CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956558557CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956561205CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956578685CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956580893CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956581036CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956584075CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956585256CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22