Duns Number:837845234
Device Description: Orthopedic surgical instrument tray - for use with the intramedullary limb lengthening sys Orthopedic surgical instrument tray - for use with the intramedullary limb lengthening system
Catalog Number
ITS2-000
Brand Name
PRECICE® Intramedullary Limb Lengthening System Instrument
Version/Model Number
ITS2-000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
c45ac0c9-4abb-441f-93f9-5bb16da40bd3
Public Version Date
September 16, 2022
Public Version Number
8
DI Record Publish Date
February 05, 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 |