FDA.reportPublic FDA data

COMEG MEDICAL TECHNOLOGIES

Primary DI
03760278260045
Brand
COMEG MEDICAL TECHNOLOGIES
Company
SOPRO
Model
UBIPACK ENT SYSTEM
Catalog number
SK101016
Device description
A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOSTICS AND TREATMENTUBIPack brings surgeons the perfect all-in-one tool for diagnosis and treatment in an office setting.
Published
2017-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCWLight Source, Fiberoptic, Routine
FWFCamera, Television, Endoscopic, Without Audio
NTNLed Light Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1
NTNLed Light SourceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103813000SOPRO 281Sopro2011-03-22NTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760278260045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760278260045037602782600453760278260045

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33556340607info@acteongroup.com

Regulatory Flags#

DUNS number
264205501
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760278260434ACTEON SYSTEME PSPIX WIN MAC (Only)9970902018-11-19
03760278260939ACTEON SYSTEME PSPIX WIN MACS_702_00112018-11-19
M430S70200111ACTEON SYSTEME PSPIX WIN MACS_702_00112016-09-24
03760278267587ACTEONC50 - INTRAORAL CAMERAS_C50_00082024-05-02
03760278267594ACTEONC50 - INTRAORAL CAMERA DS_C50_00092024-05-02
03760278267020ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278267037ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278260427COMEG MEDICALSOURCE LED SOPRO 281 BLANC (Only)9983602018-11-19
M430S21800061COMEG MEDICALSOPRO 218 - SOURCE DE LUMIERE XENON 180W - SOPRO S_218_00062016-09-24
M430S21800091COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00092016-09-24
M430S21800111COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00112016-09-24
M430S21800121COMEG MEDICALS218 SOPRO US WOLFS_218_00122016-09-24
M430S23000051COMEG MEDICALSOPRO 230 - SOURCE DE LUMIERE XENON 300W - SOPROS_230_00052016-09-24
M430S23000091COMEG MEDICALS230 SOPRO US OLYMPUSS_230_00092016-09-24
M430S23000111COMEG MEDICALS230 SOPRO US WOLFS_230_00112016-09-24
M430S28100011COMEG MEDICALSOURCE LED SOPRO 281 ORLS_281_00012016-09-24
M430S28100021COMEG MEDICALSOURCE LED SOPRO 281 BLANCS_281_00022016-09-24
M430S29800021COMEG MEDICALSOURCE LED SOPRO S298S_298_00022016-09-24
03760278260342COMEG MEDICAL TECHNOLOGIESPENTAX Medical LED Light SourceS_281P_01042019-07-16
03760278260380COMEG MEDICAL TECHNOLOGIESPENTAX Medical USB CameraS_181P_01122019-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817325025003iVisionMEDIMAX TECH INC.NTN2026-04-30
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00840319758991Hayden MedicalHayden Medical, Inc.FWF2026-04-22
08051887043286THD DIGITAL MINICAMTHD SPAFWF2025-02-20
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCNTN2024-07-22
08033638801048Pen LEDSAPI MED SPANTN2023-08-02
04250337100317C-Camsource®Joimax GmbHFWF2022-12-30
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04250337100331C-Camsource®Joimax GmbHFWF2022-12-30
04250337100348C-Camsource®Joimax GmbHFWF2022-12-30
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04250337100829Video TWISTERJoimax GmbHFWF2022-12-30
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04250337106173D-Camsource®Joimax GmbHFWF2022-12-30
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04250337108870Fibre optic cable adpaterJoimax GmbHFWF2022-12-30
04250337108887Fibre optic cable adpaterJoimax GmbHFWF2022-12-30
04250337108894Fibre optic cable adpaterJoimax GmbHFWF2022-12-30
04250337110811C-Camsource®Joimax GmbHFWF2022-12-30
04250337110835C-Camsource®Joimax GmbHFWF2022-12-30
04250337110996Fibre optic cable adpaterJoimax GmbHFWF2022-12-30
04250337111009Fibre optic cable adpaterJoimax GmbHFWF2022-12-30
04250337115212Camsource®Joimax GmbHFWF2022-12-30
04250337115229Camsource®Joimax GmbHFWF2022-12-30