Duns Number:837845234
Device Description: Orthopedic Intramedullary Limb Lengthening Rod, Universal Femur, 8.5 mm Diameter, 150 mm
Catalog Number
P8.5-50N150
Brand Name
PRECICE® Intramedullary Limb Lengthening System
Version/Model Number
P8.5-50N150
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K160325
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
a43a05e0-14c7-44f2-a31f-0f1a9aa2783c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 09, 2016
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 | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2199 |