FDA.reportPublic FDA data

OC-2300

Primary DI
00852683007704
Brand
OC-2300
Company
TOPCON MEDICAL SYSTEMS, INC.
Model
24045-NA-H2-000
Device description
OC-2300 CHAIR-NAVY-240V HIGH; Ophthalmic examination chair
Published
2022-12-07
Public version status
Update
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
HMEChair, Ophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMEChair, Ophthalmic, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852683007704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852683007704008526830077048526830077040852683007704

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic chair, line-poweredA mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).

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
00850053428609OC-220024046-CO-L1-001-GV2024-05-28
00850053428616IS-550023060-11-000-GV2024-05-28
00850053428517IS-650023090-11-0002024-05-17
00850053428524IS-650023090-22-0002024-05-17
00850053428548OC-220024046-BL-L1-0112024-03-12
00850053428555OC-220024046-CH-L1-0112024-03-12
00850053428562OC-230024045-BL-L1-0112024-03-12
00850053428579OC-230024045-CH-L1-0112024-03-12
00850053428586OC-240024048-BL-L1-0112024-03-12
00850053428593OC-240024048-CH-L1-0112024-03-12
00850053428531OC-240024048-CO-L2-0002023-11-20
00850053428500VisiChartVisiChart II2023-06-20
00850053428005OC-220024046-CR-H2-0002022-12-07
00850053428012OC-220024046-CR-L1-0002022-12-07
00850053428029OC-220024046-CR-L2-0012022-12-07
00850053428036OC-220024046-CR-H1-0002022-12-07
00850053428043OC-220024046-EG-L1-0012022-12-07
00850053428050OC-220024046-EG-L2-0002022-12-07
00850053428067OC-220024046-EG-H1-0002022-12-07
00850053428074OC-220024046-EG-H2-0002022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850003069739OC-2400TOPCON HEALTHCARE INCHME2026-03-13
04057027018781UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027071816UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027212998UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027256831UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027338476UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027552995UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027609606UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027615751UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027619605UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027637050UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027659212UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027948156UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
00850053428708OC-2200TOPCON HEALTHCARE INCHME2025-09-18
00850053428715OC-2200TOPCON HEALTHCARE INCHME2025-09-18
00850053428722OC-2200TOPCON HEALTHCARE INCHME2025-09-18
00850053428739OC-2200TOPCON HEALTHCARE INCHME2025-09-18
00850053428647OC-2300TOPCON HEALTHCARE INCHME2025-09-03
00850053428654OC-2300TOPCON HEALTHCARE INCHME2025-09-03
00850053428661OC-2200TOPCON HEALTHCARE INCHME2025-09-03
00850053428678OC-2200TOPCON HEALTHCARE INCHME2025-09-03
00850053428685OC-2400TOPCON HEALTHCARE INCHME2025-09-03
00850053428692OC-2400TOPCON HEALTHCARE INCHME2025-09-03
00628308210374S4 OPTIKBlue.S4 IncHME2025-08-21
00628308210381S4 OPTIKBlue.S4 IncHME2025-08-21
00628308210398S4 OPTIKBlue.S4 IncHME2025-08-21
05907642694602Ophthalmic Operator's ChairMDT SP Z O OHME2025-07-16
05907642694619Surgical TableMDT SP Z O OHME2025-07-16
00850053428630OC-2400TOPCON HEALTHCARE INCHME2025-05-19
00628308210190MarcoBlue.S4 IncHME2025-04-23