Duns Number:093357739
Device Description: Electrical surgical table with kidney elevator, foot pump,and low-profile, 110 V
Catalog Number
-
Brand Name
NUVO
Version/Model Number
B2AV800KPN-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDC
Product Code Name
Table, Operating-Room, Electrical
Public Device Record Key
eb69c963-fc60-49cd-a0ec-f0a0c047c268
Public Version Date
September 19, 2022
Public Version Number
2
DI Record Publish Date
January 31, 2020
Package DI Number
01816835022563
Quantity per Package
1
Contains DI Package
00816835022564
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 112 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |