FDA.reportPublic FDA data

Ophthalmic Operator's Chair

Primary DI
05907642694602
Brand
Ophthalmic Operator's Chair
Company
MDT SP Z O O
Model
OC-1
Published
2025-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05907642694602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05907642694602059076426946025907642694602

GMDN Terms#

Term, Definition table
TermDefinition
Ergonomic surgeon’s chairAn electrically-powered, wheeled device designed to be occupied by a surgeon in a seated position during ophthalmic surgery or microsurgery to provide the surgeon with support for the back and arms. It is designed with at least one electrically operated ergonomic adjustment (e.g., height and position adjustments) which is typically adjusted by hand or foot-operated controls. It typically features wheels (castors) and breaks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
366126408
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
05907642694435Refraction UnitTOROS2025-08-08
05907642694008Ophthalmic StoolT-L2025-07-16
05907642694015Ophthalmic StoolT-P2025-07-16
05907642694022Ophthalmic StoolT-S2025-07-16
05907642694039Ophthalmic StoolT-LT2025-07-16
05907642694169Ophthalmic Electric TableTTUD-10002025-07-16
05907642694176Ophthalmic Electric TableCOMBO-12025-07-16
05907642694183Ophthalmic Electric TableRT S2025-07-16
05907642694190Ophthalmic Electric TableTT-40602025-07-16
05907642694206Ophthalmic Electric TableMD-22025-07-16
05907642694213Ophthalmic Electric TableTTH-10002025-07-16
05907642694220Ophthalmic Electric TableRT VF2025-07-16
05907642694237Ophthalmic Electric TableCOMBO-22025-07-16
05907642694268Ophthalmic Electric TableRT B2025-07-16
05907642694275Ophthalmic Electric TableMD-V2025-07-16
05907642694282Ophthalmic Electric TableTT-10602025-07-16
05907642694299Ophthalmic Electric TableRT V2025-07-16
05907642694305Ophthalmic Electric TableTTVS-10002025-07-16
05907642694312Ophthalmic Electric TableMD-3V2025-07-16
05907642694329Ophthalmic Electric TableMD-32025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436566190022TOPCONANTONI CARLES SAHME2026-06-01
08436566190039TOPCONANTONI CARLES SAHME2026-06-01
08436566190046TOPCONANTONI CARLES SAHME2026-06-01
08436566190053TOPCONANTONI CARLES SAHME2026-06-01
00850003069753OC-2300TOPCON HEALTHCARE INCHME2026-05-06
00850003069760OC-2300TOPCON HEALTHCARE INCHME2026-05-06
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
00850003069630OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069647OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069654OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069661OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069678OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069685OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069692OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069708OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069715OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069722OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850053428746OC-2200TOPCON HEALTHCARE INCHME2025-10-31