Duns Number:079636174
Device Description: HIPPY Lower Extremity Package (includes HIPPY Leg Board, two HIPPY Padded Peg Board Posts HIPPY Lower Extremity Package (includes HIPPY Leg Board, two HIPPY Padded Peg Board Posts Large and two HIPPY Padded Peg Board Posts Small)
Catalog Number
925.HIPPY-LEP
Brand Name
Bone Foam
Version/Model Number
925.HIPPY-LEP
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"
Yes
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
HST
Product Code Name
Apparatus, traction, non-powered
Public Device Record Key
48e56e81-561b-489f-a092-efab946b6bbd
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 22, 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 | 97 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |