Duns Number:796416191
Device Description: Clamp, Angle 2 Hole
Catalog Number
21-3220
Brand Name
Drive Rail
Version/Model Number
21-3220
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2022
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
KTT
Product Code Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Public Device Record Key
da863bb8-4444-44ff-a3d8-855b6dc81dc7
Public Version Date
June 22, 2022
Public Version Number
5
DI Record Publish Date
December 13, 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 | 1662 |
2 | A medical device with a moderate to high risk that requires special controls. | 7273 |