FDA.reportPublic FDA data

Olympus

Primary DI
04042761002318
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
A0557
Catalog number
A0557
Published
2016-09-21
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
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761002318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761002318040427610023184042761002318

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316957240
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042761005722OlympusA3764AA3764A2016-09-21
04042761005739OlympusA3765AA3765A2016-09-21
04042761077729OlympusWA2P400AWA2P400A2016-09-21
04042761002981OlympusA2250A22502016-09-21
04042761009805OlympusA60210AA60210A2016-09-21
04042761009812OlympusA60211AA60211A2016-09-21
04042761010214OlympusA64310AA64310A2016-09-21
04042761010283OlympusA64610AA64610A2016-09-21
04042761010290OlympusA64610LA64610L2016-09-21
04042761010306OlympusA64620AA64620A2016-09-21
04042761010351OlympusA64820LA64820L2016-09-21
04042761010436OlympusA66070AA66070A2016-09-21
04042761010610OlympusA70959AA70959A2016-09-21
04042761011068OlympusA7517A75172016-09-21
04042761011082OlympusA7519A75192016-09-21
04042761020381OlympusA20975AA20975A2016-09-21
04042761021142OlympusA22073AA22073A2016-09-21
04042761021173OlympusA22083AA22083A2016-09-21
04042761021203OlympusA22087AA22087A2016-09-21
04042761023054OlympusA37000AA37000A2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051887044716THD N-Ano anoscopesTHD SPAGCP2025-03-14
18051887044778THD N-ano anoscopeTHD SPAGCP2025-03-14
18033737712273THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2017-11-14
18033737710668THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2017-07-13
38033737710723THD N-ano anoscopeTHD SPAGCP2017-01-20
28033737710016THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710023THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710030THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710047THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710054THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710061THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710078THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710085THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710092THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710108THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710115THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710122THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710139THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
38033737710143THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710153THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
38033737710167THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710177THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710184THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710191THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
28033737710207THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
38033737710334THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
38033737710341THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
18033737710361THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
18033737710385THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
18033737710392THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23