FDA.reportPublic FDA data

Olympus

Primary DI
04042761005340
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
A3575
Catalog number
A3575
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZOUrethrotome
GCPEndoscope, Ac-Powered And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZOUrethrotomeGastroenterology, Urology2
GCPEndoscope, Ac-Powered And AccessoriesGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761005340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761005340040427610053404042761005340

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-401-1086xx@xx.xx

Regulatory Flags#

DUNS number
316957240
Device count
1
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
B382SD439190Surgical DirectSurgical Direct, Inc.EZO2026-08-03
08051887044719THD N-Ano anoscopesTHD SPAGCP2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAGCP2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAGCP2025-03-14
08051887044771THD N-ano anoscopeTHD SPAGCP2025-03-14
08033737710715THD N-ano anoscopeTHD SPAGCP2018-04-12
08033737712276THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2017-11-14
08033737710661THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2017-07-13
08033737710678THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2017-07-13
10649111188558Sklar®SKLAR CORPORATIONEZO2017-06-23
08033737710722THD N-ano anoscopeTHD SPAGCP2017-01-20
08033737710012THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710029THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710036THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710043THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710050THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710067THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710074THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710081THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710098THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710104THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710111THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710128THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710135THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710142THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710159THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710166THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710173THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710180THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710197THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23