FDA.reportPublic FDA data

Optomic

Primary DI
08436041580294
Brand
Optomic
Company
OPTOMIC ESPAÑA SA
Model
OP-2000 HD Camera
Published
2024-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWDCamera, Television, Microsurgical, Without Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWDCamera, Television, Microsurgical, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436041580294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436041580294084360415802948436041580294

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

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
08436041580126OptomicOP-C2 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B366U1VI360R04Procam HD CMOS IIEclerisFWD2026-05-27
B366U1VI3605PROCAM 4K USBEclerisFWD2026-05-19
B366U1HC130G21Procam 4KEclerisFWD2025-12-22
B366U1VI3701Procam 4KEclerisFWD2025-12-22
B366AIO100BRX1PROCAM PACKEclerisFWD2025-08-22
B366AIO100SRX1PROCAM PACK SEclerisFWD2025-08-22
B366FE1023RX1PROCAM FLEXEclerisFWD2025-08-22
B366U1VI360100BRX1PROCAM PACKEclerisFWD2025-08-22
B366U1VI360100SRX1PROCAM PACK SEclerisFWD2025-08-22
B366U1VI3604RX1PROCAM HD USBEclerisFWD2025-08-22
B366U1HC120G21R06Procam HD CMOS II CONSOLEEclerisFWD2025-07-30
B366U1VI3601R04Procam HD CMOS IIEclerisFWD2025-07-30
B366U1VI3603RX2Procam HD IIEclerisFWD2025-07-30
00840306836602Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FWD2025-02-14
00840306836374Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FWD2025-01-27
B366U1VI3603RX1Procam HD IIEclerisFWD2024-09-25
00840306831058Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FWD2024-07-19
08436041580270OptomicOPTOMIC ESPAÑA SAFWD2024-07-17
B366U1VI360Procam HD CMOS IIEclerisFWD2023-09-19
M6337055100JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M633705511B0JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M63370551410JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337055160JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M63370552010JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337055250JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337055300JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M633705910280JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M633705910380JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337059240JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337059243100JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07