Duns Number:036985604
Device Description: The ShroudGuard Surround for 5000 Series Surgical Tables protects the OR table base on fou The ShroudGuard Surround for 5000 Series Surgical Tables protects the OR table base on four sides with a sturdy, metal structure that prevents accidental damage caused by the pedestal shroud cladding being lowered onto objects placed near or against the pedestal.
Catalog Number
BF069
Brand Name
NA
Version/Model Number
ShroudGuard
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
f66d366b-4a7f-488c-a028-1ea9b1c0502e
Public Version Date
April 12, 2021
Public Version Number
1
DI Record Publish Date
April 02, 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 |