FDA UDI
In Commercial Distribution
🇺🇸 United States
FHC 1000 Radiographic Top O.R. Table(220V)
DI: B337FHC1000220V1
·
Model: FHC1000K.2v03.1
·
FUTURE HEALTH CONCEPTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FHC 1000 Radiographic Top O.R. Table(220V)
- Primary DI
- B337FHC1000220V1
- Version / Model
- FHC1000K.2v03.1
- Catalog Number
- FHC1000-220V
- Company Name
- FUTURE HEALTH CONCEPTS, INC.
- Labeler DUNS
- 037304144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-08
- Public Version
- 1
- Public Version Date
- 2018-12-10
- Public Version Status
- New
- Public Device Record Key
- 67444ef1-e89a-4bb7-949d-eb9bdb0e429a
Device Description
Remote Control Operating Room Table With Radiographic Top Hi-Low 26 To 48 Trendelenburg 30 Degrees Reverse Trendelenburg 30 Degrees Side Tilt 20 Degrees Right To Left Back Section Up 80 Degrees (50 Degrees Down Reverse Orientation 80 Degrees Up 105 Degrees Down Flex Back Down 20 Degrees Maximum With Seat Down 25 Degrees Reflex Back Up 25 Degrees Return To Level Built-In Battery Back-Up Back Lit Hand Control 1000Lbs Weight Capacity. Patient Surface Is 77 3/4"" L X 203/4"" W. Overall Size Is 79"" L X 23""W. Electrical Specification Ac 220/3A 300W 50/60 Hz Single Phase. Current Leakage . <100 Micro amps.
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 |
|---|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35379 | Universal operating table, electrohydraulic | A mobile, mains electricity (AC-powered) hydraulic-mechanism 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B337FHC1000220V1 | HIBCC |