FDA.reportPublic FDA data

Olympus

Primary DI
04042761077606
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
WA51250A
Catalog number
WA51250A
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
EWYMediastinoscope, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWYMediastinoscope, SurgicalEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761077606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761077606040427610776064042761077606

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable 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
04048551425718NAKarl Storz GmbH & Co. KGEWY2025-03-27
24026704715293PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715309PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715316PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715323PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715330PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
00863189000304Aegis Illuminated Mediastinal Access PortAEGIS SURGICAL LIMITEDEWY2017-03-14
10863189000318Aegis Illuminated Mediastinal Access Port AEGIS SURGICAL LIMITEDEWY2017-03-14
00814334021644NARichard Wolf GmbHEWY2016-09-30
04055207001097NARichard Wolf GmbHEWY2016-09-26
04055207009284NARichard Wolf GmbHEWY2016-09-26
04055207014806NARichard Wolf GmbHEWY2016-09-26
04055207020623NARichard Wolf GmbHEWY2016-09-26
04048551049587n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551049594n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551049570n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551225387n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551225424n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551242889DCIKarl Storz GmbH & Co. KGEWY2016-09-23
04048551322062DCIKarl Storz GmbH & Co. KGEWY2016-09-23
04055207000014NARichard Wolf GmbHEWY2016-09-23
04055207009260NARichard Wolf GmbHEWY2016-09-23
04055207020616NARichard Wolf GmbHEWY2016-09-23
04055207020630NARichard Wolf GmbHEWY2016-09-23
04055207020647NARichard Wolf GmbHEWY2016-09-23
04055207034071NARichard Wolf GmbHEWY2016-09-23
04055207034088NARichard Wolf GmbHEWY2016-09-23
04055207034095NARichard Wolf GmbHEWY2016-09-23
04055207034101NARichard Wolf GmbHEWY2016-09-23
04055207056400NARichard Wolf GmbHEWY2016-09-23