FDA.reportPublic FDA data

Micro Manipulator UMP

Primary DI
04589698450411
Brand
Micro Manipulator UMP
Company
MITAKA KOHKI CO., LTD.
Model
UMP
Device description
"This device is designed to be used with the endoscope holder ""UniARM"" manufactured by Mitaka Kohki Co., Ltd."
Published
2019-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
GWGEndoscope, Neurological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GWGEndoscope, NeurologicalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090792000MITAKA UNIARMMitaka Kohki Co., Ltd.2009-07-06GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589698450411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589698450411045896984504114589698450411

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, power-adjustedA device assembly adjusted or stabilized by electrical, electro-pneumatic or pneumatic means, intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
692666613
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
045896984506024K3D Video Microscope HawkSightKV32022-11-30
04589698450251Surgical Microscope MM90/YOHMM90/YOH2022-11-25
04589698450268Surgical Microscope MM80/YOHMM80/YOH2022-11-26
04589698450275Surgical Microscope MM80/SOH MM80/SOH2022-11-26
04589698450534Surgical Microscope MM80/SS1MM80/SS12022-11-26
04589698450541Surgical Microscope MM51/SS1 MM51/SS12022-11-25
04589698450558Surgical Microscope MM90/SS1 MM90/SS12022-11-25
04589698450572Surgical Microscope MM90/SOHMM90/SOH2022-11-25
04589698450619Surgical Microscope MM51/SOH MM51/SOH2022-11-25
04589698450176Surgical Microscope MM51/YOHMM51/YOH2018-09-03
04589698450206Surgical 3D Video Microscope KestrelView IIKV22018-09-03
04589698450466Universal Adapter 10-15mmPS-BU-0452019-02-06
04589698450473Universal 10-15mm pediatricPS-BU-0462019-02-06
04589698450015Point SetterPSMS-22016-10-17
04589698450022UniARM UA12016-10-17
04589698450220 Mitaka 3D Viewer3DV2018-08-01
04589698450404Micro Manipulator PSMPPSMP2019-02-05
04589698450459Universal Adapter 5-10mmPS-SU-0402019-02-06
04589698450480UA Endo holder 5-10mmUH-510U2019-02-05
04589698450497UA Endo holder 10-15mmUH-1015U2019-02-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
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E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
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E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400161cCeLLVPIX Medical, Inc.GWG2026-05-11
08800112400178cCeLLVPIX Medical, Inc.GWG2026-05-11
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
076133276089151788STRYKER CORPORATIONGWG2023-12-11
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210372LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210518LaportSejong Medical Co., LtdGCJ2018-04-05