FDA.reportPublic FDA data

SINGLE USE DISTAL COVER MAJ-2315

Primary DI
14953170441278
Brand
SINGLE USE DISTAL COVER MAJ-2315
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2315
Catalog number
N6192000
Published
2022-06-01
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

Product Codes#

Code, Name table
CodeName
FDTDuodenoscope And Accessories, Flexible/Rigid
FEBAccessories, Cleaning, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDTDuodenoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FEBAccessories, Cleaning, For EndoscopeGastroenterology, 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
54953170441276PackageGS160In 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.

Sterilization Methods#

Method table
Method

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
true
Manufacturing date on label
true
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
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
00724995245962Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
04953170467370SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
10724995245969Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
14953170467377SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
00724995244392NASTERIS CORPORATIONFEB2025-10-21
00724995355470NASTERIS CORPORATIONFEB2025-10-21
00724995355487NASTERIS CORPORATIONFEB2025-10-21
04961333255801INSPIRAHOYA CORPORATIONFDT2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFDT2025-06-20
40677964055322Medivators HookupMEDIVATORS INC.FEB2025-06-10
40677964054448Medivators HookupMEDIVATORS INC.FEB2025-04-04
40677964054622Medivators HookupMEDIVATORS INC.FEB2025-04-04
05707480157167Ambu® aScope™ Duodeno 2Ambu A/SFDT2025-03-29
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04961333356355PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
04961333356331PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
05707480157143Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
05707480157136Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
10705037069316EVOTECH™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FEB2024-06-20
00724995225209NASTERIS CORPORATIONFEB2024-06-03
00724995225216NASTERIS CORPORATIONFEB2024-06-03
00724995225223NASTERIS CORPORATIONFEB2024-06-03
00724995225230NASTERIS CORPORATIONFEB2024-06-03
00724995225247NASTERIS CORPORATIONFEB2024-06-03
00724995225254NASTERIS CORPORATIONFEB2024-06-03
00724995225261NASTERIS CORPORATIONFEB2024-06-03
00724995225278NASTERIS CORPORATIONFEB2024-06-03
00724995225285NASTERIS CORPORATIONFEB2024-06-03