FDA.reportPublic FDA data

IS-5500

Primary DI
08526830083225
Brand
IS-5500
Company
TOPCON MEDICAL SYSTEMS, INC.
Model
23060-22-000
Device description
IS-5500 INSTRUMENT STAND 220/240 VOLT; AC-Powered Ophthalmic Instrument Stand
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HMFStand, Instrument, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMFStand, Instrument, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08526830083225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08526830083225085268300832258526830083225

GMDN Terms#

Term, Definition table
TermDefinition
Static ophthalmic equipment stand, manually-adjustedA device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It may have a manually-operated height adjustment function (e.g., a hydraulic foot pump or adjustable threaded column) enabling the user to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053547238
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08526830071000OC-2300240452022-12-07
08526830071017OC-230024045-AL-L1-002022-12-07
08526830071024OC-230024045-AL-L2-0002022-12-07
08526830071031OC-230024045-AL-H1-0002022-12-07
08526830071048OC-230024045-AL-H2-0002022-12-07
08526830071055OC-230024045-BL-H1-0002022-12-07
08526830071062OC-230024045-BL-H2-0002022-12-07
08526830071079OC-230024045-BL-L1-0012022-12-07
08526830071086OC-230024045-BL-L2-0002022-12-07
08526830071093OC-230024045-CB-H1-0002022-12-07
08526830071109OC-230024045-CB-H2-0002022-12-07
08526830071116OC-230024045-CB-L1-0002022-12-07
08526830071123OC-230024045-CB-L2-0002022-12-07
08526830071130OC-230024045-CC-H1-0002022-12-07
08526830071147OC-230024045-CC-H2-0002022-12-07
08526830071154OC-230024045-CC-L1-0002022-12-07
08526830071161OC-230024045-CC-L2-0002022-12-07
08526830071178OC-230024045-CH-H1-0002022-12-07
08526830071185OC-230024045-CH-H2-0002022-12-07
08526830071192OC-230024045-CH-L1-0002022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05907642694435Refraction UnitMDT SP Z O OHMF2025-08-08
00850020301607RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301614RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301621RelianceHAAG-STREIT USA, INC.HMF2025-08-04
05907642694459Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694466Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694473Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694480Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694497Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694510Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694534Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694541Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694565Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694589Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694596Refraction UnitMDT SP Z O OHMF2025-07-16
00850020301584RelianceHAAG-STREIT USA, INC.HMF2025-05-21
00850020301539RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301546RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301553RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301560RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301577RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00628308210015LombartINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210022S4 OptikINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210039MarcoINNOVA Medical Ophthalmics IncHMF2025-02-20
G699Q90630EyeCheq KioskEYECHEQ INC.HMF2024-10-17
05907642694442Refraction UnitMDT SP Z O OHMF2024-06-14
00850053428616IS-5500TOPCON HEALTHCARE INCHMF2024-05-28
00850053428517IS-6500TOPCON HEALTHCARE INCHMF2024-05-17
00850053428524IS-6500TOPCON HEALTHCARE INCHMF2024-05-17
00860010833223ILLUMINIXIlluminix Industries LLCHMF2024-01-23