FDA.reportPublic FDA data

FOOT HOLDER

Primary DI
04953170148545
Brand
FOOT HOLDER
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1205
Catalog number
GL2553
Device description
MAJ-1205 FOOT HOLDERS
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
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111425000
K202646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111425000OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190Olympus Medical Systems Corp.2012-04-20HET
K202646000Visera Elite II Video System CenterOlympus Medical Systems Corp.2020-10-29FET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170148545PrimaryGS10
84953170148541Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170148545049531701485454953170148545
8495317014854184953170148541

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

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
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840432200063CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200117CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200308CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200315CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200322CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
04048551425695n.a.Karl Storz GmbH & Co. KGFET2024-12-20
04250480101704NASCHÖLLY FIBEROPTIC GmbHFET2024-12-03
04048551436271n.a.Karl Storz GmbH & Co. KGFET2024-11-28
04048551436240n.a.Karl Storz GmbH & Co. KGFET2024-10-18
00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
00821925041462InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041486InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041523InstaClearGyrus ACMI, LLCEOB2024-04-22
07613327616682SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616699SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616705SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616712SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616729SPYSTRYKER CORPORATIONNWB2024-02-27