Duns Number:056038268
Catalog Number
-
Brand Name
3.5MM HEX DRIVER 450MM LONG
Version/Model Number
SSI006624
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
3f93f666-1097-4104-b119-353080d7f0fb
Public Version Date
November 01, 2021
Public Version Number
1
DI Record Publish Date
October 22, 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 | 8464 |
2 | A medical device with a moderate to high risk that requires special controls. | 20880 |
3 | A medical device with high risk that requires premarket approval | 133 |