Duns Number:824905723
Device Description: ASSY, Bipolar Femoral Head-Locking Ring
Catalog Number
86-1014-0-0042
Brand Name
Bipolar Femoral Head
Version/Model Number
86-1014-0-0042
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 03, 2020
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KWY
Product Code Name
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Public Device Record Key
a6732cad-da2b-4b28-8d7d-6c0380b134ff
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
October 24, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2053 |
| 3 | A medical device with high risk that requires premarket approval | 85 |