FDA.reportPublic FDA data

Small tray

Primary DI
04953170331732
Brand
Small tray
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OCS5-TYS
Device description
"""OCS5-TYS OCS-500 SMALL TRAY"""
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
HEXCOLPOSCOPE (AND COLPOMICROSCOPE)
PTZColposcope (And Colpomicroscope), Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEXColposcope (And Colpomicroscope)Obstetrics/Gynecology2
PTZColposcope (And Colpomicroscope), ExemptObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852980000OCS-2 COLPOSCOPEOlympus Corp.1985-10-23HEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170331732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170331732049531703317324953170331732

GMDN Terms#

Term, Definition table
TermDefinition
ColposcopeAn electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. It is placed directly at the opening of the vagina which is held open with an inserted speculum during colposcopy. The instrument has a light source and magnifying lenses that allow the physician to view the interior of the vagina, particularly the uterine cervix. This device is used to check for cervical cancer typically after an abnormal Papanicolaou test (PAP) or as a follow up procedure to view an abnormal area seen during an earlier gynaecological examination. During colposcopy, samples of tissue can be taken from the cervix for testing.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095528906zumaxZumax Medical Co., LTDPTZ2026-10-09
06945095528999zumaxZumax Medical Co., LTDPTZ2026-09-29
06945095528340zumaxZumax Medical Co., LTDPTZ2026-07-06
06945095528432zumaxZumax Medical Co., LTDPTZ2026-07-06
07290016976106Liger MedicalLIGER MEDICAL, LLCPTZ2026-06-02
00860005151004Liger MedicalLIGER MEDICAL, LLCPTZ2026-05-05
06944413848542UHD series Video ColposcopeEdan Instruments, Inc.PTZ2025-09-05
06944413848559UHD series Video ColposcopeEdan Instruments, Inc.PTZ2025-09-05
B366U1C200AR01MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200FR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200TR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200WR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
06944413826731UHD series Video ColposcopeEdan Instruments, Inc.PTZ2025-06-17
06944413826809UHD series Video ColposcopeEdan Instruments, Inc.PTZ2025-06-17
04250365176162ATMOSATMOS MedizinTechnik GmbH & Co. KGPTZ2024-11-27
04250365176179ATMOSATMOS MedizinTechnik GmbH & Co. KGPTZ2024-11-27
B366HC200AR00MICROSCOPE ColposcopeEclerisHEX2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeEclerisHEX2024-11-25
08436041580089OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08436041580096OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08436041580102OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08436041580119OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08436041580126OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
B366U1C200FR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200FR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
B366U1C200TR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
B366U1C200WR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
GYNX530LVCDAR0GynexGYNEX CORPORATIONHEX2023-12-19