FDA.reportPublic FDA data

Micro Manipulator PSMP

Primary DI
04589698450404
Brand
Micro Manipulator PSMP
Company
MITAKA KOHKI CO., LTD.
Model
PSMP
Device description
"This device is designed to be used with the endoscope holder ""Point Setter"" 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589698450404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589698450404045896984504044589698450404

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
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
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506092855ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506093289ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506093388ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00842102116452Deluxe Laparoscopic InstrumentsFLEXBAR MACHINE CORPORATIONGCJ2026-07-28
14026704645340WECKTELEFLEX INCORPORATEDGCJ2026-07-28
B382SD901365500Surgical DirectSurgical Direct, Inc.GCJ2026-07-28
00190776422110MillenniumAvalign Technologies, Inc.GCJ2026-07-24
00198506091957ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092848ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
14026704645333WECKTELEFLEX INCORPORATEDGCJ2026-07-21
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14