Duns Number:313267265
Device Description: TiAl6V4 ELI non-sterile
Catalog Number
GB10906
Brand Name
OsteoBridge™ IDSF Diaphysis Nail
Version/Model Number
9 60
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 11, 2020
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
K051965
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
0c1c8e28-1922-4295-95d8-ee2e590f3114
Public Version Date
February 12, 2020
Public Version Number
5
DI Record Publish Date
October 15, 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 | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 1327 |
U | Unclassified | 13 |