Duns Number:958758146
Device Description: Synthetic Sheepskin Bed Overlay (30" x 40")
Catalog Number
SS3040
Brand Name
Synthetic Sheepskin Bed Overlay
Version/Model Number
SS3040
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
FMR
Product Code Name
Device, Transfer, Patient, Manual
Public Device Record Key
6cf31cb0-dfcc-42c5-9dc3-1b5e57afbf32
Public Version Date
September 09, 2020
Public Version Number
2
DI Record Publish Date
February 27, 2019
Package DI Number
00810006683370
Quantity per Package
6
Contains DI Package
00810006682373
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 | 208 |