FDA.reportPublic FDA data

SINGLE USE DISTAL COVER

Primary DI
04953170403019
Brand
SINGLE USE DISTAL COVER
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2315
Catalog number
N5786100
Device description
SINGLE USE DISTAL COVER MAJ-2315
Published
2020-01-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDTDuodenoscope and accessories, flexible/rigid
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170403016PackageGS120In Commercial Distribution
54953170403014PackageGS160Not in Commercial Distribution
04953170403019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317040301614953170403016
5495317040301454953170403014
04953170403019049531704030194953170403019

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

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
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
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
14961333232960PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333232991PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333246233PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04953170063749EYEPIECE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDT2021-12-20
04953170064012LIGHTGUIDE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDT2021-12-20
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170338496VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170026324KEY BOARDOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-16
04547410446081FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04547410446104FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04547410429046FUJIFILMFUJIFILM CORPORATIONFDT2021-02-04
04042761083485OlympusOLYMPUS Winter & Ibe GmbHNWB2020-07-31
04042761083492OlympusOLYMPUS Winter & Ibe GmbHNWB2020-07-31
04547410384543FUJIFILMFUJIFILM CORPORATIONNWB2020-07-20
08714729995746EXALT™ Model DBOSTON SCIENTIFIC CORPORATIONFDT2020-06-05
04547410420685FUJIFILMFUJIFILM CORPORATIONNWB2020-03-15
08714729983514EXALT™ Model DBOSTON SCIENTIFIC CORPORATIONFDT2019-12-23
B747EAI0496EndochEndoch IncNWB2019-10-01
B747EAI0502EndochEndoch IncNWB2019-10-01
B747EAI0503EndochEndoch IncNWB2019-10-01
B747EAI0535EndochEndoch IncNWB2019-10-01
B747EAI0628EndochEndoch IncNWB2019-10-01