FDA.reportPublic FDA data

Single use adaptor biopsy valve

Primary DI
04953170181009
Brand
Single use adaptor biopsy valve
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1414
Catalog number
N1775730
Device description
MAJ-1414 SINGLE USE ADPATER BIOPSY VALV
Published
2016-09-21
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
FCGBiopsy needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170181009PrimaryGS10
84953170181005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170181009049531701810094953170181009
8495317018100584953170181005

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic procedure air/water valve, single-useA sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. 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
10
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
08033860002398BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002633BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860019976BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860027179BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043421BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043438BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002572BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860016272BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860027810BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041847BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041854BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041861BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041878BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041885BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041892BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041908BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041915BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041922BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041939BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041946BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041953BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041960BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860001728BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001742BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001766BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860002558BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860017361BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860041779BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860041786BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860041793BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03