Duns Number:036985604
Device Description: The STERIS 4095 Table ABS Velcro 2-inch TLT Pads is a hydraulic and electromechanically dr The STERIS 4095 Table ABS Velcro 2-inch TLT Pads is a hydraulic and electromechanically driven surgical table intended to position and support the full patient body during diagnostic examinations and or surgical procedures.
Catalog Number
ST012910002
Brand Name
STERIS
Version/Model Number
4095 Surigical 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
FQO
Product Code Name
TABLE, OPERATING-ROOM, AC-POWERED
Public Device Record Key
0819f659-df08-4e01-96bb-813128e1d734
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 |