FDA.reportPublic FDA data

FOOT HOLDER

Primary DI
04953170239588
Brand
FOOT HOLDER
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1750
Device description
MAJ-1750 OBCU FOOT HOLDER
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDAEnteroscope and accessories
FEDendoscopic access overtube, gastroenterology-urology
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071254000SMALL INTESTINAL VIDEOSCOPE SYSTEMOlympus Medical Systems Corporation2008-03-25FDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170239588PrimaryGS10
84953170239584Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170239588049531702395884953170239588
8495317023958484953170239584

GMDN Terms#

Term, Definition table
TermDefinition
Desk mountA non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
4
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450457372C2 CryoBalloon™Merit Medical Systems, Inc.FED2026-08-21
06973356551462ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551479ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551493ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551509ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551660ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551677ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551684ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551691ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551707ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551714ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
04953170421594HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.NWB2026-07-22
06973356551738TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551745TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551752TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551769TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551776TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551783TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
00348783012415Premier Jackson Improved Short Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYFDA2026-06-10
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06970462547457Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10