FDA.reportPublic FDA data

JEDMED

Primary DI
M6337055160
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
70-5516
Catalog number
70-5516
Device description
HANGER KIT F/DIGICAM
Published
2023-02-07
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
M6337055160PrimaryHIBCC0

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
092987189
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03
M6339977120JEDMED99-771299-77122023-02-03
M6339977400JEDMED99-774099-77402023-02-03
M6339977410JEDMED99-774199-77412023-02-03
M6339977420JEDMED99-774299-77422023-02-03
M6339977430JEDMED99-774399-77432023-02-03
M6339977450JEDMED99-774599-77452023-02-03
M6339977460JEDMED99-774699-77462023-02-03
M63399774610JEDMED99-7746-199-7746-12023-02-03
M6339977470JEDMED99-774799-77472023-02-03
M6339977480JEDMED99-774899-77482023-02-03
M6339977490JEDMED99-774999-77492023-02-03
M6339977500JEDMED99-775099-77502023-02-03
M6339978000JEDMED99-780099-78002023-02-03
M6339978100JEDMED99-781099-78102023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08436041580294OptomicOPTOMIC 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
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
M633705924310FF0JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07