FDA.reportPublic FDA data

INDIRECT OPHTHALMOSCOPE BINOCULAR

Primary DI
04053755119660
Brand
INDIRECT OPHTHALMOSCOPE BINOCULAR
Company
Heine Optotechnik GmbH & Co. KG
Model
3,5 V
Catalog number
C-002.33.002
Published
2022-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04053755119660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755119660040537551196604053755119660

GMDN Terms#

Term, Definition table
TermDefinition
Indirect binocular ophthalmoscopeAn electrically-powered, head-worn, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s two eyes simultaneously (stereoscopic vision). It is intended to provide a wide field of view and produce an inverted (reversed) image of approximately 2 to 5 times magnification. It typically consists of a main light to illuminate the interior of the eyeball, lenses, filters and an illuminator beam to eliminate reflexes; it can be mounted on a headband or spectacle frames.

Contacts#

Phone, Email table
PhoneEmail
+1 (603) 742-7103service@heine-na.com

Regulatory Flags#

DUNS number
315274563
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053755203567BETA X VET OPHTHALMOSCOPE000G-140.28.3302026-03-31
04053755203574BETA X VET OTOSCOPE000G-130.28.3302026-03-31
04053755207541XV4 BETA X VET SPECULUM4 MMG-000.21.3202026-03-31
04053755207558XV6 BETA X VET SPECULUM6 MMG-000.21.3212026-03-31
04053755207565X CHANGE SYSTEM SL-MAGNIFIER 000G-000.21.2202026-03-31
04053755180172HEINE SIGMA®250000C-008.33.3402016-09-24
04053755180738HEINE SIGMA®250000C-008.33.3412016-09-24
04053755202690DELTA 30 UV002026-03-02
04053755203314DELTA XLEDK-130.28.3302025-12-03
04053755203321DELTA X CPP00K-000.34.2372025-12-03
04053755203338DELTA X CPG00K-000.34.2382025-12-03
04053755202904BETA X Otoscope3xB-130.28.3302025-07-18
04053755202911BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755202744BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755203031BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755202973FINOFF TRANSILLUMINATOR2,5 VC-001.17.0802025-07-17
04053755202966BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755203048GAMMA 3.2000M-000.09.9472025-07-17
04053755202928DELTAoneBLACK WHITE EDITIONK-214.28.3052025-04-30
04053755136988GAMMA 3.1000M-000.09.9412022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095544135zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544197zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544500zumaxZumax Medical Co., LTDHLI2026-05-20
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
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
00732094347036Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05