Cerviray

Primary DI
08800126000050
Brand
Cerviray
Company
AIDOT
Model
ADT-CC10
Catalog number
D-23-090
Device description
The Cerviray is a handheld device that includes imaging optics, provides sequentially captured images of the cervix. The image can be viewed on the touch screen display. It typically consists of an illuminated lens and video camera unit connected to an LCD touch screen display. During use, Cerviray is used with the speculum(not provided) to keep a certain distance to obtain good quality of image and prevent direct contact with patient. The Cradle is also included for charging purpose only.
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PTZColposcope (And Colpomicroscope), Exempt

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800126000057PackageGS12In Commercial Distribution
08800126000050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880012600005718800126000057
08800126000050088001260000508800126000050

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius75 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689847125
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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
06944413808409Video ColposcopeEdan Instruments, Inc.PTZ2017-11-23
04953170331718Light guideOLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21
04953170331725Eyepiece shape TV mountOLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21
04953170331732Small trayOLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21
04953170331756COLPOSCOPE OCS-500 SYSTEM RACKOLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21
04953170331770COLPOSCOPE OCS-500 DIGITAL CAMERA ADAPTEROLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21