FDA UDI
In Commercial Distribution
🇺🇸 United States
KLYO
DI: B773KMOPT0
·
Model: KMOPT
·
KLYO MEDICAL SYSTEMS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KLYO
- Primary DI
- B773KMOPT0
- Version / Model
- KMOPT
- Company Name
- KLYO MEDICAL SYSTEMS INC.
- Labeler DUNS
- 058639417
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-22
- Public Version
- 1
- Public Version Date
- 2024-03-01
- Public Version Status
- New
- Public Device Record Key
- 5a5ce349-2963-4d70-8b4d-29c03373ccdb
Device Description
Mobile, operating tables (Mechanical Operating Tables, Hydraulic Operating Tables) designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions to satisfy the requirements of many clinical specialties.
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 |
|---|---|---|---|---|
| FWX | Table, Operating-Room, Mechanical | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58034 | Universal operating table, hydraulic | A mobile, manually-operated hydraulic table designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface) to satisfy the requirements of many clinical specialties. It is typically operated via an integral foot-pedal(s) that adjust the table top position. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B773KMOPT0 | HIBCC |
Customer Contacts
- Phone
- 3053305025
- [email protected]