FDA.reportPublic FDA data

Olympus

Primary DI
04042761051880
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
WA33038A
Catalog number
WA33038A
Device description
Sheath, 28Fr.
Published
2016-09-21
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
FGAKit, Nephroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853486000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853486000OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPEOlympus Corp.1985-09-12FGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761051880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761051880040427610518804042761051880

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. 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
00191506062514Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062576Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
10810068811114MONARCH™ Mini-PCNL Suction SetAuris Health, Inc.FGA2026-05-05
06925816667213ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816667220ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816657511ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657528ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657535ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657542ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657559ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657566ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657573ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657580ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657597ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657603ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657610ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657627ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657634ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657641ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657658ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657672ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26