FDA.reportPublic FDA data

Single Use Stent Insertion Kit V

Primary DI
04953170347382
Brand
Single Use Stent Insertion Kit V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1818
Catalog number
N4535530
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
14953170347389PackageGS11In Commercial Distribution
04953170347382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317034738914953170347389
04953170347382049531703473824953170347382

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
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
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170347399Single 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