VALVULOTOME (DETACHABLE TYPE)

Primary DI
14953170047692
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWXSTRIPPER, ARTERY, INTRALUMINAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895878000OLYMPUS VALVULOTOME W/DETACHABLE TIPOlympus Corp.1990-01-02DWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170047692PackageGS11In 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
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

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
04953170047695VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
14953170047678VALVULOTOME (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
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