Duns Number:190572854
Device Description: RIGIDFIX Femoral Rod Bone Tendon Bone Only 11.5mm, 30-120mm (Plus or Minus 6 Percent)
Catalog Number
213721
Brand Name
RIGIDFIX
Version/Model Number
213721
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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
eba8a68b-b375-4c0c-9cde-5d1aace87618
Public Version Date
October 05, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2015
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 | 560 |
2 | A medical device with a moderate to high risk that requires special controls. | 479 |