Duns Number:480151859
Device Description: Universal patient positioning belt for MR and CT imaging.
Catalog Number
1230
Brand Name
ProBelt 50 VL C
Version/Model Number
ProBelt 50 VL C
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
8f7aac7b-46f7-4b8f-8f18-2f68616e146f
Public Version Date
May 18, 2022
Public Version Number
1
DI Record Publish Date
May 10, 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 |