Duns Number:315675488
Device Description: E-Dur® Insert - shouldered with offset
Catalog Number
183-864/28
Brand Name
MobileLink Acetabular Cup System
Version/Model Number
183-864/28
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
K182321
Product Code
LPH
Product Code Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Public Device Record Key
b53d8cf3-73b7-4072-a288-3da115f76ced
Public Version Date
September 17, 2019
Public Version Number
1
DI Record Publish Date
September 09, 2019
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 | 154 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3922 |
| U | Unclassified | 42 |