FDA.reportPublic FDA data

Point Setter

Primary DI
04589698450015
Brand
Point Setter
Company
MITAKA KOHKI CO., LTD.
Model
PSMS-2
Device description
The Pointsetter is indicated for use as a holder for an endoscope
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04589698450015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589698450015045896984500154589698450015

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
04589698450022UniARM UA12016-10-17
04589698450220 Mitaka 3D Viewer3DV2018-08-01
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
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