FDA.reportPublic FDA data

HD EndoEYE LAPARO-THORACO VIDEOSCOPE

Primary DI
04953170287015
Brand
HD EndoEYE LAPARO-THORACO VIDEOSCOPE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS LTF TYPE VH
Device description
LTF-VH ENDOEYE FLEX 10 HD VIDEOSCOPE
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080948000HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VHOlympus Medical Systems Corporation2008-09-26HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170287015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170287015049531702870154953170287015

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170467875THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type STB-0535FCSR50016442026-10-29
04953170467882THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSR50016452026-10-29
04953170047671VALVULOTOME (DETACHABLE TYPE)C-0103B2016-09-21
04953170047695VALVULOTOME (DETACHABLE TYPE)C-0104B2016-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551158913n.a.Karl Storz GmbH & Co. KGGCJ2026-11-04
04048551158937n.a.Karl Storz GmbH & Co. KGGCJ2026-11-04
04251303804093TrokamedTROKAMED GmbHGCJ2026-11-03
04251303804116TrokamedTROKAMED GmbHGCJ2026-11-03
04251303808916TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809036TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809043TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809050TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809067TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809074TrokamedTROKAMED GmbHGCJ2026-11-03
04251303810933TrokamedTROKAMED GmbHGCJ2026-11-03
04251303817611TrokamedTROKAMED GmbHGCJ2026-11-03
04048551431603n.a.Karl Storz GmbH & Co. KGGCJ2026-11-02
08904332600803MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2026-11-02
B382SD13108150Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD15908450Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD32154290Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD13517450Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD13518130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD15908130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD77505940Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19