FDA.reportPublic FDA data

JEDMED

Primary DI
M63339742820
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
39-7428-2
Catalog number
39-7428-2
Device description
Ophthalmoscope Lens 45-Deg Series 2
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M63339742820PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Direct ophthalmoscopeAn electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a built-in light directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
314-845-3770info@jedmed.com

Regulatory Flags#

DUNS number
092987189
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M63330170506L0JEDMED30-1705 06L30-1705 06L2020-09-01
M63330170506R0JEDMED30-1705 06R30-1705 06R2020-09-01
M63330170579H0JEDMED30-1705 79H30-1705 79H2020-09-01
M6333018340JEDMED30-183430-18342020-09-01
M6333018350JEDMED30-183530-18352020-09-01
M6333018360JEDMED30-183630-18362020-09-01
M6333103500JEDMED31-035031-03502020-09-01
M6333103510JEDMED31-035131-03512020-09-01
M6333104600JEDMED31-046031-04602020-09-01
M6333104750JEDMED31-047531-04752020-09-01
M63331047570JEDMED31-0475 731-0475 72020-09-01
M6333104760JEDMED31-047631-04762020-09-01
M63331047650JEDMED31-0476 531-0476 52020-09-01
M6333104770JEDMED31-047731-04772020-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06942576062461RobotrakRobotrak Technologies Co., LtdHLI2026-04-30
00697077003081Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2025-07-14
04549292147216CANON INC.CANON INC.HLI2025-05-02
00697077003050Amico Diagnostic, Inc.Amico Diagnostic IncorporatedHLI2024-09-18
00697077003043Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2024-07-11
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2024-05-02
00732094086515Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094089202Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00697077002237Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2023-07-27
04053755119660INDIRECT OPHTHALMOSCOPE BINOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755120307INDIRECT OPHTHALMOSCOPE MONOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755153541OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755153695OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181704OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181711OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
00732094346930Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346947Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346954Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346961Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094347555Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346978Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346985Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346992Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347005Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347012Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347029Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05