Duns Number:080506581
Device Description: SELF CENTERING BI-POLAR HEAD 28mm ID 52mm OD
Catalog Number
103552000
Brand Name
SELF CENTERING
Version/Model Number
1035-52-000
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
Yes
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
K812672
Product Code
KWY
Product Code Name
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Public Device Record Key
6963028f-11f9-4815-a204-9ba1aacf7ce6
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
September 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 | 5254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
| 3 | A medical device with high risk that requires premarket approval | 908 |