Duns Number:036985604
Device Description: The SurgicGraphic 6000 Surgical Table is primarily designed for minimally invasive endovas The SurgicGraphic 6000 Surgical Table is primarily designed for minimally invasive endovascular, vascular, cardiovascular, pain management, and other procedures requiring intra-operative fluoroscopic C-Arm imaging.
Catalog Number
TA01
Brand Name
Surgigraphic
Version/Model Number
Surgigraphic 6000 Table
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)
Yes
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
c7fc7f16-625f-430c-9b91-cdb11036a55c
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |