Duns Number:080503619
Device Description: AdvantageRib Locking Cap, Medium, Hex Drive
Catalog Number
323.1006
Brand Name
AdvantageRib
Version/Model Number
323.1006
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
K141241
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
1e32a04f-448f-45da-a6db-a2d7d5c5e6ed
Public Version Date
October 04, 2018
Public Version Number
4
DI Record Publish Date
February 17, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 35 |