FDA.reportPublic FDA data

SINGLE USE DISTAL COVER

Primary DI
04953170441271
Brand
SINGLE USE DISTAL COVER
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2315
Catalog number
N6192000
Published
2022-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDTDuodenoscope And Accessories, Flexible/Rigid
FEBAccessories, Cleaning, For Endoscope
NWBEndoscope, Accessories, Narrow Band Spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDTDuodenoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220587000Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.2022-05-11FDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170441278PackageGS120In Commercial Distribution
54953170441276PackageGS160Not in Commercial Distribution
04953170441271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317044127814953170441278
5495317044127654953170441276
04953170441271049531704412714953170441271

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope patient protection cap, single-useAn invasive device, typically in the form of a detachable cap, designed to cover the exposed mechanical components at the distal end of an endoscope (e.g., duodenoscope) during an endoscopic procedure to protect the patient from injury. This is a single-use device.

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921391PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
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04580826921438PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926693PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926709PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926778PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926792PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826928406PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826928499PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONFDT2026-08-25
04953170421594HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.NWB2026-07-22
00724995245962Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
00724995244392NASTERIS CORPORATIONFEB2025-10-21
00724995355470NASTERIS CORPORATIONFEB2025-10-21
00724995355487NASTERIS CORPORATIONFEB2025-10-21
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
00860010835210Scope Assist Flushing Sink (SAFS)Wassenburg Medical, Inc.FEB2024-04-23
00860010835227Scope Assist Flushing Sink (SAFS)Wassenburg Medical, Inc.FEB2024-04-23
00677964051555Medivators HookupMEDIVATORS INC.FEB2024-04-01
00677964053450Medivators HookupMEDIVATORS INC.FEB2024-04-01
07613327616682SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616699SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616705SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616712SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616729SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616743SPYSTRYKER CORPORATIONNWB2024-02-27
076133276089151788STRYKER CORPORATIONNWB2023-12-11
G434SYSTEM83PLUS2SYSTEM 83 PLUSWassenburg Medical, Inc.FEB2023-08-15