FDA.reportPublic FDA data

Optomic

Primary DI
08436041580126
Brand
Optomic
Company
OPTOMIC ESPAÑA SA
Model
OP-C2 COLPOSCOPE
Published
2024-07-18
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
08436041580126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436041580126084360415801268436041580126

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
564165678
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436041580485OptomicOP-30 Naso-pharyngoscope2024-08-01
08436041580089OptomicOP-C12 COLPOSCOPE (45) 2024-07-18
08436041580096OptomicOP-C16 COLPOSCOPE (45) 2024-07-18
08436041580102OptomicOP-C5 COLPOSCOPE 2024-07-18
08436041580119OptomicOP-C2L COLPOSCOPE 2024-07-18
08436041580362OptomicOP-S10 CHAIR 2024-07-18
08436041580379OptomicOP-S8 CHAIR 2024-07-18
08436041580386OptomicOP-S6 CHAIR 2024-07-18
08436041580393OptomicOP-S7 CHAIR 2024-07-18
08436041580409OptomicOP-S4 CHAIR 2024-07-18
08436041580416OptomicOP-S10 CHAIR (STRUCTURE) 2024-07-18
08436041580423OptomicOP-S8 CHAIR (STRUCTURE)2024-07-18
08436041580430OptomicOP-S6 CHAIR (STRUCTURE) 2024-07-18
08436041580447OptomicOP-S7 CHAIR (STRUCTURE)2024-07-18
08436041580454OptomicOP-S4 CHAIR (STRUCTURE)2024-07-18
08436041580461OptomicOP-G7+ CHAIR (GOEPEL) 2024-07-18
08436041580478OptomicOP-G7+ CHAIR (FOOT SUPPORTS) 2024-07-18
08436041580522OptomicOTOSCOPE OPT 1,9mm x 100mm x 0 AUT.2024-07-18
08436041580539OptomicOTOSCOPE OPT 1,9mm x 100mm x 30 AUT.2024-07-18
08436041580577OptomicOTOSCOPE OPT 2,7mm x 75mm x 0 AUT.2024-07-18

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
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