Duns Number:342243334
Device Description: 2.4 LC SS angle stable polyax. plate, str.,4 h.,33mm
Catalog Number
150-6224-104
Brand Name
2.4 LC SS angle stable polyax. plate, str.,4 h.,33mm
Version/Model Number
150-6224-104
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
57d7c95c-5094-4dbe-b6f1-b81c0bd0aa99
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 02, 2016
Package DI Number
EMAH15062241041
Quantity per Package
1
Contains DI Package
EMAH15062241040
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |