Duns Number:016889401
Catalog Number
-
Brand Name
Synthes
Version/Model Number
310.44
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
-
Product Code
HTW
Product Code Name
Bit, Drill
Public Device Record Key
a8c49895-b981-4858-8b23-5a0303c6b77f
Public Version Date
April 23, 2020
Public Version Number
2
DI Record Publish Date
December 12, 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 | 3993 |
2 | A medical device with a moderate to high risk that requires special controls. | 1216 |