Duns Number:873149871
Device Description: THE PREFERX DELIVERY SYSTEM IS INTENDED TO BE USED FOR THE DELIVERY OF HYDRATED ALLOGRAFT, THE PREFERX DELIVERY SYSTEM IS INTENDED TO BE USED FOR THE DELIVERY OF HYDRATED ALLOGRAFT, AUTOGRAFT, OR SYNTHETIC BONE GRAFT MATERIAL TO AN ORTHOPEDIC SURGICAL SITE.
Catalog Number
15100
Brand Name
PREFERX DELIVERY SYSTEM, DISPOSABLE
Version/Model Number
15-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K210997
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
10393e6e-db7a-461c-9b05-dfaeb259c052
Public Version Date
October 07, 2021
Public Version Number
1
DI Record Publish Date
September 29, 2021
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |