FDA.reportPublic FDA data

WiScope®

Primary DI
10850023925296
Brand
WiScope®
Company
Otu Medical Inc.
Model
OTU-OM100S
Device description
Single-Use Digital Flexible Ureteroscope/Choledochoscope
Published
2023-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850023925296PackageGS110In Commercial Distribution
00850023925299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002392529610850023925296
00850023925299008500239252998500239252990850023925299

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. It is typically introduced via a flexible duodenoscope and anatomical images are transmitted to a monitor for viewing typically through a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
100796993
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00850023925237WiScope®OTU-OM100SR2023-04-30
00850023925244WiScope®OTU-OM100RR2023-04-30
00850023925251WiScope®OTU-OM100SL2023-04-30
00850023925268WiScope®OTU-OM100RL2023-04-30
00850023925299WiScope®OTU-OM100S2023-04-30
00850023925305WiScope®OTU-OM100R2023-04-30
00850023925381AptraBDCYSD012024-09-30
00850023925398AptraBDCYRD012024-09-30
00850023925428WiScope®OTU-C311S2024-09-30
00850023925435WiScope®OTU-C311R2024-09-30
10850023925388AptraBDCYSD012024-09-30
10850023925395AptraBDCYRD012024-09-30
10850023925425WiScope®OTU-C311S2024-09-30
10850023925432WiScope®OTU-C311R2024-09-30
00850023925169WiScope®OTU-C300S2022-04-18
00850023925176WiScope®OTU-C300R2022-04-18
00850023925183WiScope®OTU-C310S2022-04-18
00850023925190WiScope®OTU-C310R2022-04-18
00850023925329WiScope®OTU-120R4101U0601T2024-01-12
00850023925336WiScope®OTU-120S4101U0501T2024-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.FGB2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.FGB2026-05-05
10810068811107MONARCH™ Urology Irrigation CartridgeAuris Health, Inc.FGB2026-05-04
10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
06972520301216Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
00810116023370Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023417Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023523Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023585Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
06971176282924Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13