FDA.reportPublic FDA data

VALVULOTOME (DETACHABLE TYPE)

Primary DI
04953170047671
Brand
VALVULOTOME (DETACHABLE TYPE)
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
C-0103B
Device description
VALVULOTOME (DETACHABLE TYPE)
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

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
14953170047678PackageGS11In Commercial Distribution
04953170047671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317004767814953170047678
04953170047671049531700476714953170047671

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
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
00763000358822NAMEDTRONIC, INC.DWX2020-02-17
10885403034992V. MuellerCAREFUSION 2200, INCDWX2016-09-23
04953170047695VALVULOTOME (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