FDA.reportPublic FDA data

OLYMPUS

Primary DI
14953170403016
Brand
OLYMPUS
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2315
Device description
SINGLE USE DISTAL COVER MAJ-2315
Published
2020-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193182000Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.2020-01-17FDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170403016PackageGS120In Commercial Distribution
54953170403014PackageGS160In 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 detachable end-cap, single-useA detachable plastic cap for an endoscope (e.g., duodenoscope) designed to cover the exposed mechanical components at the distal end of the endoscope during a single use. It is intended as an alternative to the common non-detachable distal end-cap of an endoscope and serves no function other than to cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170421594HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.NWB2026-07-22
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
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170437960ETO CAPOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-04-22
04953170434754EVIS EXERA III BRONCHOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-04-20
04953170434778EVIS EXERA III BRONCHOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-04-20
04953170434792EVIS EXERA III BRONCHOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-04-20
04953170452031TROCAR INTRODUCER FOR LTF 5MM SCOPE MAJ-1379OLYMPUS MEDICAL SYSTEMS CORP.NWB2022-07-25
04953170411526RHINO-LARYNGO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-24
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170338496VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170386015VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170386060VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170026324KEY BOARDOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-16
04547410446081FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04547410446104FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-02-07
04953170409820CONNECTING TUBEOLYMPUS MEDICAL SYSTEMS CORP.NWB2020-12-15
04042761083485OlympusOLYMPUS Winter & Ibe GmbHNWB2020-07-31
04042761083492OlympusOLYMPUS Winter & Ibe GmbHNWB2020-07-31
04547410384543FUJIFILMFUJIFILM CORPORATIONNWB2020-07-20
04953170386077VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300OLYMPUS MEDICAL SYSTEMS CORP.NWB2020-06-04