Duns Number:480151859
Device Description: Universal patient positioning aid for MR and CT imaging.
Catalog Number
1161
Brand Name
ProFoam Wedge 18x11x5 DS
Version/Model Number
ProFoam Wedge 18x11x5 DS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXH
Product Code Name
Cradle, Patient, Radiologic
Public Device Record Key
2244b7e7-b066-4fbf-8cc5-570ec94b24e0
Public Version Date
May 19, 2022
Public Version Number
1
DI Record Publish Date
May 11, 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 | 126 |