Duns Number:079398589
Device Description: Rod Reducer Driver
Catalog Number
64-RD-0453
Brand Name
Reform Ti CT Modular MIS Pedicle Screw System
Version/Model Number
64-RD-0453
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXX
Product Code Name
Screwdriver
Public Device Record Key
c08d0388-e9ec-4f04-8d6d-b23eb1808280
Public Version Date
July 05, 2021
Public Version Number
1
DI Record Publish Date
June 25, 2021
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 | 1423 |
2 | A medical device with a moderate to high risk that requires special controls. | 4960 |
U | Unclassified | 26 |