FDA UDI
In Commercial Distribution
🇺🇸 United States
ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL
DI: B510OT300C0
·
Model: OT-300 C
·
ADVANCED INSTRUMENTATIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL
- Primary DI
- B510OT300C0
- Version / Model
- OT-300 C
- Company Name
- ADVANCED INSTRUMENTATIONS, INC.
- Labeler DUNS
- 608736880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-27
- Public Version
- 1
- Public Version Date
- 2020-06-04
- Public Version Status
- New
- Public Device Record Key
- 09a78a06-7ab6-4b5d-b1c7-4b220a29e81b
- Distribution End Date
- 2028-04-30
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 |
|---|---|---|---|---|
| GDC | Table, Operating-Room, Electrical | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45400 | Orthopaedic operating table, electromechanical | A mobile, electrically-powered motorized table designed to support a patient and to provide traction for the limb(s)/spine of the patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted, and it is often intended to be used with additional patient positioners. It may have x-ray transparent features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B510OT300C0 | HIBCC |