Duns Number:023574260
Device Description: Disposable foam chest roll 5" x 17"
Catalog Number
-
Brand Name
Voss Chest Roll 5" x 17"
Version/Model Number
714-CR
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
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
NXH
Product Code Name
Nursing Pad, Cohesive Gel
Public Device Record Key
64cefb92-2b7a-4600-831f-cd97210c5688
Public Version Date
January 08, 2019
Public Version Number
2
DI Record Publish Date
June 11, 2018
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 | 12 |