FDA.report

OC-2200

Primary DI
08526830071666
Brand
OC-2200
Company
TOPCON MEDICAL SYSTEMS, INC.
Model
24046-BL-L1-001
Device description
OC-2200 CHAIR BLACK 120 LOW; Ophthalmic examination chair
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

Related Records

Product Codes

CodeName
HMEChair, Ophthalmic, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HMEChair, Ophthalmic, Ac-PoweredOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08526830071666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08526830071666085268300716668526830071666

GMDN Terms

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

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 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

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Primary DIBrandCompanyProduct codePublished
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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
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05907642694602Ophthalmic Operator's ChairMDT SP Z O OHME2025-07-16
05907642694619Surgical TableMDT SP Z O OHME2025-07-16
00850053428630OC-2400TOPCON HEALTHCARE INCHME2025-05-19
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