Duns Number:036985604
Device Description: The STERIS 5095 General Surgical Table SS with Velcro without Pads is a flexible design gi The STERIS 5095 General Surgical Table SS with Velcro without Pads is a flexible design gives OR staff the versatility they need to perform a wide range of surgeries using a variety of patient positions.
Catalog Number
ST015210000
Brand Name
STERIS
Version/Model Number
5095 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
a45e0ae6-3d81-423c-af45-8880074cf8d6
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 |