FDA.reportPublic FDA data

Olympus

Primary DI
14042761000212
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
00131
Catalog number
00131
Device description
Sealing cap, 0.7 mm, 10 pieces
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
FGBUreteroscope And Accessories, Flexible/Rigid
GCPEndoscope, Ac-Powered And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2
GCPEndoscope, Ac-Powered And AccessoriesGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14042761000212PrimaryGS10
04042761000215Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404276100021214042761000212
04042761000215040427610002154042761000215

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic biopsy valve, non-sterileA non-sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use 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
10
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
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.FGB2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.FGB2026-05-05
10810068811114MONARCH™ Mini-PCNL Suction SetAuris Health, Inc.FGA2026-05-05
10810068811107MONARCH™ Urology Irrigation CartridgeAuris Health, Inc.FGB2026-05-04
10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00860005357741CVAC Aspiration SystemCalyxo, Inc.FGB2025-09-10
08881300750107F88SG ENDOSCOPY PTE. LTD.FGB2025-06-30
00810143891294Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
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
00860005357710CVAC Aspiration SystemCalyxo, Inc.FGB2024-02-22
00860005357727CVAC Image ProcessorCalyxo, Inc.FGB2024-02-22
00850023925329WiScope®Otu Medical Inc.FGB2024-01-12
00850023925336WiScope®Otu Medical Inc.FGB2024-01-12
00850023925237WiScope®Otu Medical Inc.FGB2023-04-30
00850023925244WiScope®Otu Medical Inc.FGB2023-04-30
00850023925251WiScope®Otu Medical Inc.FGB2023-04-30
00850023925268WiScope®Otu Medical Inc.FGB2023-04-30
00850023925299WiScope®Otu Medical Inc.FGB2023-04-30
00850023925305WiScope®Otu Medical Inc.FGB2023-04-30
00724995209162Uretero1BLACK DIAMOND VIDEO, INC.FGB2022-06-10