FDA.reportPublic FDA data

Single Use Stent Insertion Kit V

Primary DI
14953170347396
Brand
Single Use Stent Insertion Kit V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1819
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECATHETER, BILIARY, DIAGNOSTIC
QGEBiliary Stent, Drain, And Dilator Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
QGEBiliary Stent, Drain, And Dilator AccessoriesGastroenterology, Urology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103478000SINGLE USE BILIARY DRAINAGE STENT VOlympus Medical Systems Corporation2011-02-24FGE

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.

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
true
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
15711055100400M-DrainMermaid Medical A/SFGE2024-10-01
15711055110041M-DrainMermaid Medical A/SFGE2024-07-20
15711055110409M-DrainMermaid Medical A/SFGE2024-07-20
15711055120040M-DrainMermaid Medical A/SFGE2024-01-31
15711055120453M-DrainMermaid Medical A/SFGE2024-01-31
15711055000311M-DrainMermaid Medical A/SFGE2016-09-24
15711055000328M-DrainMermaid Medical A/SFGE2016-09-24
15711055000359M-DrainMermaid Medical A/SFGE2016-09-24
15711055000373M-DrainMermaid Medical A/SFGE2016-09-24
15711055000410M-DrainMermaid Medical A/SFGE2016-09-24
15711055000434M-DrainMermaid Medical A/SFGE2016-09-24
15711055000458M-DrainMermaid Medical A/SFGE2016-09-24
15711055000472M-DrainMermaid Medical A/SFGE2016-09-24
15711055000496M-DrainMermaid Medical A/SFGE2016-09-24
15711055000519M-DrainMermaid Medical A/SFGE2016-09-24
15711055000533M-DrainMermaid Medical A/SFGE2016-09-24
15711055000557M-DrainMermaid Medical A/SFGE2016-09-24
15711055000588M-DrainMermaid Medical A/SFGE2016-09-24
15711055000595M-DrainMermaid Medical A/SFGE2016-09-24
15711055000625M-DrainMermaid Medical A/SFGE2016-09-24
15711055000632M-DrainMermaid Medical A/SFGE2016-09-24
15711055000663M-DrainMermaid Medical A/SFGE2016-09-24
15711055000670M-DrainMermaid Medical A/SFGE2016-09-24
15711055000700M-DrainMermaid Medical A/SFGE2016-09-24
15711055000724M-DrainMermaid Medical A/SFGE2016-09-24
15711055000748M-DrainMermaid Medical A/SFGE2016-09-24
15711055000762M-DrainMermaid Medical A/SFGE2016-09-24
15711055000779M-DrainMermaid Medical A/SFGE2016-09-24
15711055000809M-DrainMermaid Medical A/SFGE2016-09-24
15711055000816M-DrainMermaid Medical A/SFGE2016-09-24