FDA.reportPublic FDA data

Single Use Stent Insertion Kit V

Primary DI
04953170347399
Brand
Single Use Stent Insertion Kit V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1819
Catalog number
N4535630
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
QGEBiliary Stent, Drain, And Dilator Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGEBiliary Stent, Drain, And Dilator AccessoriesGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170347396PackageGS11In Commercial Distribution
04953170347399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317034739614953170347396
04953170347399049531703473994953170347399

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic stent-placement systemAn assembly of sterile devices inserted through a compatible flexible endoscope to implant a stent, typically into a pancreatic or biliary duct in order to maintain patency. It typically consists of a positioning catheter onto which the stent is loaded, a guiding device (commonly known as an introducer or guidewire) that aids the initial placement of the stent, and a pusher catheter that holds the stent in place during withdrawal of the other component devices. It is commonly made of polytetrafluoroethylene (PTFE) [Teflon], or polyethylene (PE). 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
04953170347382Single Use Stent Insertion Kit VOLYMPUS MEDICAL SYSTEMS CORP.QGE2016-09-21
04953170347405Single Use Stent Insertion Kit VOLYMPUS MEDICAL SYSTEMS CORP.QGE2016-09-21
04953170347412Single Use Stent Insertion Kit VOLYMPUS MEDICAL SYSTEMS CORP.QGE2016-09-21
14953170347389Single Use Stent Insertion Kit VOLYMPUS MEDICAL SYSTEMS CORP.QGE2016-09-21
14953170347396Single Use Stent Insertion Kit VOLYMPUS MEDICAL SYSTEMS CORP.QGE2016-09-21
14953170347402Single Use Stent Insertion Kit VOLYMPUS MEDICAL SYSTEMS CORP.QGE2016-09-21
14953170347419Single Use Stent Insertion Kit VOLYMPUS MEDICAL SYSTEMS CORP.QGE2016-09-21