Duns Number:837845234
Device Description: Orthopedic surgical instrument (fracture reducer-humerus) - for use with the trauma intram Orthopedic surgical instrument (fracture reducer-humerus) - for use with the trauma intramedullary rod
Catalog Number
HFR2-000
Brand Name
PRECICE® Trauma Nail System
Version/Model Number
HFR2-000
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
HWN
Product Code Name
Instrument, Compression
Public Device Record Key
f42b0cd5-8919-4d7c-8726-2710da23702e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 02, 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 |