FDA.reportPublic FDA data

Lens Cleaner

Primary DI
04953170213489
Brand
Lens Cleaner
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MA-2
Device description
MA-002 LENS CLEANER
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBOCYSTOURETHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBOCystourethroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K843084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K843084000OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPEOlympus Corp.1985-01-03FBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170213489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170213489049531702134894953170213489

GMDN Terms#

Term, Definition table
TermDefinition
Medical device-decontamination agentA non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Manufacturing date on label
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04953170438158Biopsy ValveOLYMPUS MEDICAL SYSTEMS CORP.FBO2023-04-22
04055207066218E-LINERichard Wolf GmbHFBO2020-02-21
04055207066225E-LINERichard Wolf GmbHFBO2020-02-21
04055207066195E-LINERichard Wolf GmbHFBO2020-02-21
04055207066201E-LINERichard Wolf GmbHFBO2020-02-21
04048551327746n.a.Karl Storz GmbH & Co. KGFBO2019-02-23
04048551390139n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390160n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390184n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390238n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390146n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390177n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
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00821925001947Elite BipolarGyrus ACMI, LLCFBO2016-10-13
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00821925008229USA Elite Gyrus ACMI, LLCFBO2016-10-05
00821925008243EliteGyrus ACMI, LLCFBO2016-10-05
00821925027275Gyrus ACMIGyrus ACMI, LLCFBO2016-10-05
04055207018385NARichard Wolf GmbHFBO2016-09-29
04055207018392NARichard Wolf GmbHFBO2016-09-29
04055207018491NARichard Wolf GmbHFBO2016-09-29
04055207018194MOXYRichard Wolf GmbHFBO2016-09-27
04055207018231GREENLIGHTRichard Wolf GmbHFBO2016-09-27
04055207018255GREENLIGHTRichard Wolf GmbHFBO2016-09-27
04055207018286E-LINERichard Wolf GmbHFBO2016-09-27