Duns Number:092820703
Device Description: DISPOSABLE HEEL REST PAD (12 Pair) DISPOSABLE HEEL REST PAD (12 Pair)
Catalog Number
10379
Brand Name
Schaerer Medical USA
Version/Model Number
10379
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
ead06022-91e9-44b0-913a-2ded14a12bb6
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 16, 2022
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 | 110 |