Duns Number:860396609
Device Description: 2.5 mm Hex Driver Assembly - Pin Driver
Catalog Number
F003.0005
Brand Name
2.5 mm Hex Driver Assembly
Version/Model Number
F003.0005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
b180a5c5-1b74-4099-82ba-4b5459ec54d7
Public Version Date
January 28, 2021
Public Version Number
1
DI Record Publish Date
January 20, 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 | 55 |
2 | A medical device with a moderate to high risk that requires special controls. | 124 |