FDA.reportPublic FDA data

WiScope®

Primary DI
00850023925268
Brand
WiScope®
Company
Otu Medical Inc.
Model
OTU-OM100RL
Device description
Single-Use Digital Flexible Ureteroscope/Choledochoscope
Published
2023-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBNCholedochoscope And Accessories, Flexible/Rigid
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850023925265PackageGS110In Commercial Distribution
00850023925268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002392526510850023925265
00850023925268008500239252688500239252680850023925268

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video choledochoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. Also known as a cholangioscope, it is inserted into the body through an artificial orifice or introduced via a flexible duodenoscope during choledochoscopy. Anatomical images are transmitted to a monitor for viewing typically through a complementary metal oxide semiconductor (CMOS) chip at the distal end. This is a single-use device.

Regulatory Flags#

DUNS number
100796993
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023925442WiScope®OTU-C380SL (OTU-300S)2026-07-28
00850023925459WiScope®OTU-C380RL (OTU-C300R)2026-07-28
00850023925466WiScope®OTU-C380SR (OTU-C310S)2026-07-28
00850023925473WiScope®OTU-C380RR (OTU-C310R)2026-07-28
00850023925558WiScope®OTU-T Pro4202T1101T2026-07-28
00850023925565WiScope®OTU-C320S2026-07-28
00850023925572WiScope®OTU-C320R2026-07-28
00850023925589WiScope®OTU-C330S2026-07-28
00850023925596WiScope®OTU-C330R2026-07-28
00850023925602WiScope®OTU-140R2026-07-28
00850023925619WiScope®OTU-140S2026-07-28
00850023925626WiScope®OTU-110R2026-07-28
00850023925633WiScope®OTU-110S2026-07-28
00850023925640WiScope®OTU-130R2026-07-28
00850023925657WiScope®OTU-130S2026-07-28
00850023925909WiScope®OTU-CK320S2026-07-28
00850023925916WiScope®OTU-CK320R2026-07-28
00850023925923WiScope®OTU-CK330S2026-07-28
00850023925930WiScope®OTU-CK330R2026-07-28
00850023925954WiScope®OTU-T Pro4202T1201T2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140474WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140481WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140535WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140542WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFBN2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFBN2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140757WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140764WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140771WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140788WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140795AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140801AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28