FDA UDI
In Commercial Distribution
🇺🇸 United States
UFSK-OSYS Treatment table
DI: 04057027972793
·
Model: 400 XL
·
UFSK-International OSYS GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UFSK-OSYS Treatment table
- Primary DI
- 04057027972793
- Version / Model
- 400 XL
- Catalog Number
- 14000001
- Company Name
- UFSK-International OSYS GmbH
- Labeler DUNS
- 332808919
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-02
- Public Version
- 1
- Public Version Date
- 2026-03-10
- Public Version Status
- New
- Public Device Record Key
- 54f929e2-fc1a-4ee1-ac36-fdd3ad7a5e2c
Device Description
Treatment table for positioning and support of the patient for outpatient microsurgical treatments in ophthalmology, ENT and dental surgery
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FWY | Table, Operating-Room, Non-Electrical | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42486 | Examination/treatment table, hydraulic | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04057027972793 | GS1 |