FDA.reportPublic FDA data

UNICO ColpoMaster II

Primary DI
00816668020065
Brand
UNICO ColpoMaster II
Company
UNITED PRODUCTS & INSTRUMENTS
Model
CS-205LED
Catalog number
CS-205LED
Device description
CS-205LED Colposcope Center Post, Binocular Zoom Head, Five Legged Base. LED Illumination
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K073053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073053000COLPO-MASTERUnited Products & Instruments, Inc.2007-11-15HEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816668020065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816668020065008166680200658166680200650816668020065

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
(732)274-1155info@unicosci.com

Regulatory Flags#

DUNS number
796269165
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816668020157UNICOL-BC92020-01-16
00816668020003UNICOCMH30CMH302016-08-23
00816668020010UNICO POWERSPIN BXC882C8822016-08-23
00816668020096UNICO POWERSPIN BXC885C8852017-04-10
00816668020102UNICO POWERSPIN BXC884C8842017-04-21
00816668020027UNICO ColpoMaster ICS-103LEDCS-103LED2016-08-23
00816668020034UNICO ColpoMaster ICS-103T-LEDCS-103T-LED2016-08-23
00816668020041UNICO ColpoMaster ICS-105LEDCS-105LED2016-08-23
00816668020058UNICO ColpoMaster ICS-105T-LEDCS-105T-LED2016-08-23
00816668020072UNICO ColpoMaster IICS-205T-LEDCS-205T-LED2016-08-23
00816668020089UNICO ColpoMaster IIICS-305CS-3052016-08-23

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