FDA.reportPublic FDA data

UFSK-OSYS Treatment table

Primary DI
04057027972793
Brand
UFSK-OSYS Treatment table
Company
UFSK-International OSYS GmbH
Model
400 XL
Catalog number
14000001
Device description
Treatment table for positioning and support of the patient for outpatient microsurgical treatments in ophthalmology, ENT and dental surgery
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWYTable, Operating-Room, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWYTable, Operating-Room, Non-ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057027972793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057027972793040570279727934057027972793

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, hydraulicA mobile table powered by manually-operated hydraulic mechanisms designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some hinged sections that can be adjusted into a raised position. The height of the table top surface will also be hydraulically-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
332808919
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
04057027018781UFSK-OSYS Surgeon's chairsurgiForce with comfort seat260000042026-03-02
04057027071816UFSK-OSYS Treatment chaireyeForce180000002026-03-02
04057027171257UFSK-OSYS Assistant's chairassistPro H240000092026-03-02
04057027212998UFSK-OSYS Surgeon's chairsurgiTrend with dynamic seat220000102026-03-02
04057027233726UFSK-OSYS Instrument tablesupportLine335100262026-03-02
04057027256831UFSK-OSYS Surgeon's chairsurgiForce light with formed seat260000092026-03-02
04057027338476UFSK-OSYS Treatment chair500 ECO150000082026-03-02
04057027349366UFSK-OSYS Assistant's chairassistPro F240000052026-03-02
04057027552995UFSK-OSYS Treatment chair500 XLS150000052026-03-02
04057027609606UFSK-OSYS Treatment chair500 XLE150000062026-03-02
04057027615751UFSK-OSYS Surgeon's chairsurgiForce with formed seat260000082026-03-02
04057027619605UFSK-OSYS Surgeon's chairsurgiLine with comfort seat220000132026-03-02
04057027637050UFSK-OSYS Surgeon's chairsurgiTrend with comfort seat220000122026-03-02
04057027659212UFSK-OSYS Surgeon's chairsurgiLine with formed seat220000082026-03-02
04057027753217UFSK-OSYS Assistant's chairassistTrend250000022026-03-02
04057027768129UFSK-OSYS Assistant's chaireasyLine F240000202026-03-02
04057027777473UFSK-OSYS Assistant's chaireasyLine R240000222026-03-02
04057027896099UFSK-OSYS Assistant's chairassistLine240000152026-03-02
04057027924617UFSK-OSYS Assistant's chaireasyPro F240000102026-03-02
04057027948156UFSK-OSYS Surgeon's chairsurgiForce light with comfort seat260000062026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840763101169Ulthera System CartUlthera, Inc.FWY2024-05-21
B510OT30K0ADVANCED TABLE, OPERATING-ROOM, NON-ELECTRICALADVANCED INSTRUMENTATIONS, INC.FWY2020-05-27