Duns Number:063519193
Device Description: Surgical Sliding Tabletop Cover (Disposable) To be used with Steris 4085, Steris 5085, Ste Surgical Sliding Tabletop Cover (Disposable) To be used with Steris 4085, Steris 5085, Steris 5085 SRT
Catalog Number
BF508
Brand Name
Steris
Version/Model Number
31765
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"
Yes
For Single-Use
Yes
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
7ad2a346-9bab-4fd7-898d-bf384fb5d189
Public Version Date
April 12, 2022
Public Version Number
1
DI Record Publish Date
April 04, 2022
Package DI Number
10618125161093
Quantity per Package
10
Contains DI Package
00618125161096
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |