FDA.reportPublic FDA data

Mitaka 3D Viewer

Primary DI
04589698450220
Brand
Mitaka 3D Viewer
Company
MITAKA KOHKI CO., LTD.
Model
3DV
Device description
The 3D Viewer provides three-dimensional image for endoscopic surgery.
Published
2018-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EPTMicroscope, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPTMicroscope, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589698450220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589698450220045896984502204589698450220

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
Chlorine Dioxide

Regulatory Flags#

DUNS number
692666613
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID 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
04589698450404Micro Manipulator PSMPPSMP2019-02-05
04589698450411Micro Manipulator UMPUMP2019-02-05
04589698450459Universal Adapter 5-10mmPS-SU-0402019-02-06
04589698450480UA Endo holder 5-10mmUH-510U2019-02-05
04589698450497UA Endo holder 10-15mmUH-1015U2019-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EON MEDITECH PRIVATE LIMITEDEPT2026-03-13
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.EPT2025-11-22
07630003501421M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501629M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501636M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501643M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630802405906ARveo 8xLeica Microsystems (Schweiz) AGEPT2025-09-17
04547497753058Mielscope +YOSHIDA DENTAL MFG. CO., LTD., THEEPT2025-09-01
B366U1OM200CLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200CR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200FLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200FR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200TLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200TR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200WLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200WR02MICROSCOPEEclerisEPT2025-06-30
06941877821456EighteethChangzhou Sifary Medical Technology Co., Ltd.EPT2025-04-17
04048551432099NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432105NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432174NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432518NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551469262NAKarl Storz GmbH & Co. KGEPT2025-03-28
06977585090051EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090099EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090129EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090136EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
00840183528461BR Surgical, LLCBR Surgical, LLCEPT2024-11-07
00840183528553BR Surgical, LLCBR Surgical, LLCEPT2024-11-05
00840183528546BR Surgical, LLCBR Surgical, LLCEPT2024-10-25
00840183528560BR Surgical, LLCBR Surgical, LLCEPT2024-10-24