Duns Number:837845234
Device Description: Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb le Orthopedic surgical instrument (flexible reamer) - for use with the intramedullary limb lengthening system
Catalog Number
RMR1-070
Brand Name
PRECICE® Intramedullary Limb Lengthening System Instrument
Version/Model Number
RMR1-070
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
HTO
Product Code Name
Reamer
Public Device Record Key
23162d2a-52aa-49de-bacb-f8fa71aaa0b9
Public Version Date
March 29, 2018
Public Version Number
2
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 |