Duns Number:355804758
Device Description: FirstStep Select Cirrus, Overlay
Catalog Number
-
Brand Name
FIRST STEP CIRRUS
Version/Model Number
203604-RF
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
FNM
Product Code Name
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Public Device Record Key
4e6bf957-86ed-4d53-9c5f-cbd1da6d70c9
Public Version Date
August 01, 2022
Public Version Number
3
DI Record Publish Date
January 31, 2017
Package DI Number
15055982784884
Quantity per Package
3
Contains DI Package
05055982784887
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 420 |
2 | A medical device with a moderate to high risk that requires special controls. | 840 |