FDA.reportPublic FDA data

VALVULOTOME (DETACHABLE TYPE)

Primary DI
04953170047695
Brand
VALVULOTOME (DETACHABLE TYPE)
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
C-0104B
Device description
VALVULOTOME (DETACHABLE TYPE)
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWXSTRIPPER, ARTERY, INTRALUMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWXStripper, Artery, IntraluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170047692PackageGS11Not in Commercial Distribution
04953170047695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317004769214953170047692
04953170047695049531700476954953170047695

GMDN Terms#

Term, Definition table
TermDefinition
ValvulotomeA hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000358822NAMEDTRONIC, INC.DWX2020-02-17
10885403034992V. MuellerCAREFUSION 2200, INCDWX2016-09-23
04953170047671VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
14953170047678VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
14953170047692VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
24026704518955PILLINGTELEFLEX INCORPORATEDDWX2016-09-16
24026704518962PILLINGTELEFLEX INCORPORATEDDWX2016-09-16
04026704518944PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518951PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518968PillingTELEFLEX INCORPORATEDDWX2016-09-16
00840663102693MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102709MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102716MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102723MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102730MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102747MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105823MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105830MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105847MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105854MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105861MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105878MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105885MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105892MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105908MultiTASC Dissection/Transection Device sizing toolLemaitre Vascular, Inc.DWX2015-07-15
00840663102563Periscope DissectorLemaitre Vascular, Inc.DWX2015-06-30
00840663102570Martin DissectorLemaitre Vascular, Inc.DWX2015-06-30
00840663102587EndoHelix Retrieval DeviceLemaitre Vascular, Inc.DWX2015-06-30