FDA.report

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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCPEndoscope, Ac-Powered And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GCPEndoscope, Ac-Powered And AccessoriesGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04042761005340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042761005340040427610053404042761005340

GMDN Terms

TermDefinition
Manual scalpel blade, reusableAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. The device is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-401-1086xx@xx.xx

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 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 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