Duns Number:154815062
Device Description: Frame for structural support of a canopy to prevent patient from exiting bed unassisted
Catalog Number
-
Brand Name
Soma Safe Enclosure
Version/Model Number
SSE 450
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FNL
Product Code Name
BED, AC-POWERED ADJUSTABLE HOSPITAL
Public Device Record Key
20dc2770-fec5-41a8-aea5-33c9b5e99fab
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 04, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |