Duns Number:109903521
Device Description: CONQUEST FN PROXIMAL COMPRESSION HANDLE
Catalog Number
71179214
Brand Name
CONQUEST FN
Version/Model Number
71179214
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
K152686
Product Code
JDO
Product Code Name
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Public Device Record Key
419cbd9a-bc3b-4818-a754-414def4b8b44
Public Version Date
August 09, 2018
Public Version Number
4
DI Record Publish Date
March 30, 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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |