FDA.reportPublic FDA data

Gynescope system, cart

Primary DI
77290018240013
Brand
Gynescope system, cart
Company
ILLUMIGYN LTD
Model
01
Catalog number
IL-100-100-900
Device description
Gynescope system, cart
Published
2020-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEXColposcope (And Colpomicroscope)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190187000Gynescope SystemIllumigyn , Ltd.2019-05-08HEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
77290018240013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7729001824001377290018240013

GMDN Terms#

Term, Definition table
TermDefinition
Video colposcope camera/monitorAn electrically-powered device intended to be placed in a video colposcope speculum (not included) to record and display images and videos during examination of the tissues of the vagina, cervix, and external genitalia. It typically consists of an illuminated lens and video camera unit connected to an image display monitor with incorporated software for receiving and viewing the transmitted images/videos. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97225476319support@illumigyn.com

Regulatory Flags#

DUNS number
600627621
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
57290018240026Gynescope, console system01IL-100-100-1002020-11-26
67290018240016Gynescope Image acquistion system01IL-100-100-2002020-11-26
17290018240011GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs01IL-100-100-0002020-11-20
27290018240018Gynescope single use vaginal speculume size small 60 units01IL-100-200-2102020-09-25
37290018240015Gynescope single use vaginal speculum size medium 60 units01IL-100-200-3102020-09-25
47290018240012Gynescope single use vaginal speculum size large 60 units01IL-100-200-4102020-09-25
57290018240019Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each01IL-100-200-5002020-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B366U1C200AR01MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200FR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200TR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200WR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366HC200AR00MICROSCOPE ColposcopeEclerisHEX2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeEclerisHEX2024-11-25
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
GYNX530LVCDAT0GynexGYNEX CORPORATIONHEX2023-12-19
GYNX530VCDAR0GynexGYNEX CORPORATIONHEX2023-12-19
GYNX530VCDAT0GynexGYNEX CORPORATIONHEX2023-12-19
05060477110263DYSIS ViewDYSIS MEDICAL LIMITEDHEX2023-12-01
B366MC400MICROSTAR ColposcopeEclerisHEX2023-08-22
B366MC410MICROSTAR ColposcopeEclerisHEX2023-08-22
B366C100FHD1MICROSTAR ColposcopeEclerisHEX2023-08-18
B366U1C100FHD1MICROSTAR ColposcopeEclerisHEX2023-08-18
B366U1C200TRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200WRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200ARX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200FRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B632MDB01039MedibluMedisono, LLCHEX2022-05-06
B632MDB01038MedibluMEDIBLU MEDICAL LLCHEX2020-12-28
B632MDB01036MedibluMEDIBLU MEDICAL LLCHEX2020-12-18
57290018240026Gynescope, console systemILLUMIGYN LTDHEX2020-11-26
67290018240016Gynescope Image acquistion systemILLUMIGYN LTDHEX2020-11-26