Duns Number:796416191
Device Description: 3 mm 90° HEX WRENCH
Catalog Number
30-0054
Brand Name
Drive Rail System
Version/Model Number
30-0054
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
HXC
Product Code Name
WRENCH
Public Device Record Key
2d6fdd2c-d254-417c-a023-72bfc901db84
Public Version Date
June 27, 2022
Public Version Number
1
DI Record Publish Date
June 17, 2022
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 |