FDA.reportPublic FDA data

HANGER ADAPTER SET

Primary DI
04953170165801
Brand
HANGER ADAPTER SET
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1151
Published
2021-12-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDAEnteroscope And Accessories
PGUSpatial Imaging For Display Of Endoscope Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2
PGUSpatial Imaging For Display Of Endoscope PositionGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002749000ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13DThe Olympus Optical Co.2000-12-04FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170165801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170165801049531701658014953170165801

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly 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

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
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

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04547410491715FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
04547410514056FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410491712FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410514053FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
10197106523643CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
50197106523641CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
10197106447185CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
50197106447183CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
10860006600805AncoraAspero Medical, Inc.FDA2023-10-26
00847627004703CD138 + Cyclin D1BIOCARE MEDICAL LLCFDA2023-06-21
04547410467284FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410324280FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410467260FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
14547410467281FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410463439FUJIFILMFUJIFILM CORPORATIONFDA2022-01-30
04953170165825PROBE ARM SET AOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-17
04953170165825PROBE ARM SET AOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165849PROBE ARM SET BOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-17
04953170165849PROBE ARM SET BOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170077722LCD Monitor Cable AOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170077746Reference Plate CoverOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170077753External Marker Cover BOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170077760External Marker Cover AOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170077777SPARE FUSEOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170165740STOPPEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165740STOPPEROLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170165757WATER RESISTANT CAPOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165757WATER RESISTANT CAPOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16