Duns Number:283658730
Device Description: Body support, with hooks and utility band, Medium
Catalog Number
-
Brand Name
Handi-Move Body Support
Version/Model Number
1030M 00000001
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
-
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
FSA
Product Code Name
Lift, patient, non-ac-powered
Public Device Record Key
ca324b2f-93fc-44df-9505-7fb0126bb8fa
Public Version Date
October 29, 2020
Public Version Number
1
DI Record Publish Date
October 21, 2020
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 | 260 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |