FDA.reportPublic FDA data

RESIGHT 500

Primary DI
04049539072023
Brand
RESIGHT 500
Company
Carl Zeiss Meditec AG
Model
302721-9020-000
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRMMicroscope, Operating & Accessories, Ac-Powered, OphthalmicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049539072023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049539072023040495390720234049539072023

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342228620
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049471097153SL 220SL 8002026-01-13
04049471091489VISULASVISULAS yag2026-01-12
04049471091496VISULASVISULAS combi2026-01-12
04049471091502VISULAS greenVISULAS green2026-01-12
04049471090260AT 030AT 0302018-12-04
04049471091229VISULAS TrionVISULAS Trion, VISULAS Trion VITE2016-09-20
04049471091403VISULAS 532sVISULAS 532s, VISULAS 532s VITE2016-09-20
04049539072122QEVO72122017-08-24
04049539072139QEVO ECU72132017-08-24
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539101563INTRABEAM® Spherical Applicator 1.5 cm304534-6000-5572017-04-14
04049539101570INTRABEAM® Spherical Applicator 2.0 cm304534-6000-5582017-04-14
04049539101587INTRABEAM® Spherical Applicator 2.5 cm304534-6000-5592017-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04064434000209Heidelberg OPERAMunich Surgical Imaging GmbHHRM2026-05-14
00380650008374UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008381UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008398UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008404UNITYAlcon Laboratories, Inc.HRM2026-04-09
04049584037909Cable SDI BIOM 6 for Alcon LuxOR RevaliaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8xOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8xOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevaliaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLumaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037695Focusing Module BIOM 6, 175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037701Focusing Module BIOM 6, 200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037718Precision Mount for B&LOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037725Precision Mount for LeicaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037732Precision Mount for AlconOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037749Precision Mount for ZeissOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037756Precision Mount for Haag StreitOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037152BIOM 6OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-14
00454745102558INAMIINAMI & CO., LTD.HRM2025-11-12
04547451081777INAMIINAMI & CO., LTD.HRM2025-11-12
07630802403711PROVEO 8xLeica Microsystems (Schweiz) AGHRM2025-10-03
04064434000193SeeLuma Digital Binoculars ModuleMunich Surgical Imaging GmbHHRM2025-08-05
06972039971061MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
06972039971078MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
06972039971221MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
01836230004391Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
01836230004407Microscope Cover MITAKA mm80, mm90, 80/276PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
02836230004390Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
02836230004406Microscope Cover MITAKA mm80, mm90, 80/276PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16