FDA.reportPublic FDA data

Olympus

Primary DI
04042761000024
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
00103
Catalog number
00103
Device description
Adapter, with Luer-lock male and x-mas tree
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZOUrethrotome
FGBUreteroscope And Accessories, Flexible/Rigid
GCPEndoscope, Ac-Powered And Accessories
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZOUrethrotomeGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2
GCPEndoscope, Ac-Powered And AccessoriesGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761000024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761000024040427610000244042761000024

GMDN Terms#

Term, Definition table
TermDefinition
Low-pressure tubing connector, reusableA device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
316957240
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042761082297OlympusWA03300AWA03300A2016-09-22
04042761082303OlympusWA03310AWA03310A2016-09-22
14042761083369OlympusWT645010WT6450102023-06-20
04042761083324OlympusWT806450WT8064502023-01-27
04042761081757OlympusWA97013AWA97013A2023-06-20
04042761083102OlympusWT2187002023-06-20
04042761083119OlympusWT2187052023-06-20
04042761083126OlympusWT2187112023-06-20
04042761083133OlympusWT2187202023-06-20
04042761083140OlympusWT6304002023-06-20
04042761083164OlympusWT6400212023-06-20
04042761083171OlympusWT645001WT6450012023-06-20
04042761083188OlympusWT645006WT6450062023-06-20
04042761083218OlympusWT645013WT6450132023-06-20
04042761083225OlympusWT645016WT6450162023-06-20
04042761083232OlympusWT645017WT6450172023-06-20
04042761083256OlympusWT645020WT6450202023-06-20
04042761083263OlympusWT645025WT6450252023-06-20
04042761083270OlympusWT645030WT6450302023-06-20
04042761083287OlympusWT645031WT6450312023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083954154Resectr Resection Device 5FR (1.65 mm)Axora Medical, Inc.HIH2026-09-24
00850083954161Resectr Resection Device 9FR (3.0 mm)Axora Medical, Inc.HIH2026-09-24
00850083954352HERizon RD5 Resecting DeviceAxora Medical, Inc.HIH2026-09-24
06972520302534Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302541Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302558Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302565Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302831Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302848Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302855Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302862Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
B382SD439190Surgical DirectSurgical Direct, Inc.EZO2026-08-03
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