FDA UDI
In Commercial Distribution
🇺🇸 United States
NUVO
DI: 00816835022342
·
Model: B2AV1000KN-2
·
Medical Illumination International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NUVO
- Primary DI
- 00816835022342
- Version / Model
- B2AV1000KN-2
- Company Name
- Medical Illumination International Inc.
- Labeler DUNS
- 093357739
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-31
- Public Version
- 2
- Public Version Date
- 2022-09-19
- Public Version Status
- Update
- Public Device Record Key
- c51faae4-5bfa-4bb2-9b29-9895bac4ad87
Device Description
Electrical surgical table with kidney elevator and low-profile, 220 V
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 01816835022341 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 00816835022342 | GS1 |