FDA.reportPublic FDA data

ATMOS

Primary DI
04250365176162
Brand
ATMOS
Company
ATMOS MedizinTechnik GmbH & Co. KG
Model
i View 21 COLPO
Device description
The device is a colposcope and intended to give a magnified illuminated spacial view on human tissue (genital area) for diagnostic and treatment purposes
Published
2024-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04250365176162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250365176162042503651761624250365176162

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

Regulatory Flags#

DUNS number
319591939
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
04250365195071ATMOSC 051 Thorax2025-03-25
04250365142273ATMOSVariotherm plus2024-11-27
04250365142297ATMOSHygrotherm plus2024-11-27
04250365143065ATMOSVarioair2024-11-27
04250365149791ATMOSC 21 Economy - function column (230 V~)2024-11-27
04250365149807ATMOSC 21 Economy - function column (115 V~)2024-11-27
04250365149814ATMOSC 21 Economy - function column (127 V~)2024-11-27
04250365149821ATMOSC 31 Economy - function column (230 V~)2024-11-27
04250365149838ATMOSC 31 Economy - function column (115 V~)2024-11-27
04250365149845ATMOSC 31 Economy - function column (127 V~)2024-11-27
04250365155471ATMOSHL 21 LED2024-11-27
04250365155488ATMOSHL 21 LED (examination set)2024-11-27
04250365155495ATMOSHL 21 LED (OT set)2024-11-27
04250365155839ATMOSLS 21 LED2024-11-27
04250365155860ATMOSLS 21 LED set, white2024-11-27
04250365156034ATMOSStrobo 21 LED2024-11-27
04250365164084ATMOSS 61 Servant ENT workstation (230 V~)2024-11-27
04250365164107ATMOSS 61 Servant ENT workstation (115 V~)2024-11-27
04250365164114ATMOSS 61 Servant ENT workstation (127 V~)2024-11-27
04250365166187ATMOSS 61 Servant Vision2024-11-27

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
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
08800126000050CervirayAIDOTPTZ2023-06-14
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