Duns Number:837845234
Device Description: Orthopedic surgical instrument (entry drill) - for use with the intramedullary limb length Orthopedic surgical instrument (entry drill) - for use with the intramedullary limb lengthening system
Catalog Number
CED1-011
Brand Name
PRECICE® Intramedullary Limb Lengthening System
Version/Model Number
CED1-011
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
-
Product Code
HTW
Product Code Name
Bit, Drill
Public Device Record Key
6fc2c4e8-f0d3-450c-8cd6-284c34ab60cd
Public Version Date
November 22, 2018
Public Version Number
4
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 |