Duns Number:488133448
Device Description: Alloclassic®, SL stem, uncemented, 3, taper 12/14
Catalog Number
-
Brand Name
Alloclassic® Zweymüller® SL
Version/Model Number
2843
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
K030373
Product Code
JDI
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Public Device Record Key
4bc1c68f-27bd-480d-9f24-d90761ee9d24
Public Version Date
October 14, 2019
Public Version Number
3
DI Record Publish Date
August 29, 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 | 338 |
2 | A medical device with a moderate to high risk that requires special controls. | 3101 |