Duns Number:036985604
Device Description: The STERIS OT 1100 Series Orthopedic Surgical Table without drive package performs a varie The STERIS OT 1100 Series Orthopedic Surgical Table without drive package performs a variety of orthopedic procedures, including anterior hips, maximizing operational efficiency while maintaining patient and staff safety.
Catalog Number
BEA57240001841
Brand Name
STERIS
Version/Model Number
OT 1100 Orthopedic 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
JEA
Product Code Name
TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
Public Device Record Key
3d4847c3-8525-4863-a4e0-a235b9745afa
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 |