Duns Number:690713813
Catalog Number
78540
Brand Name
CS031 contra shank
Version/Model Number
CS031
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKX
Product Code Name
HANDPIECE, DIRECT DRIVE, AC-POWERED
Public Device Record Key
10e3e3a0-0fed-40ca-80ca-9edab22f80be
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
September 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 | 56 |
2 | A medical device with a moderate to high risk that requires special controls. | 108 |
U | Unclassified | 8 |