Duns Number:008162518
Device Description: Screwdriver Bit star 3 1/2" T5 SQC
Catalog Number
gS 86.1605
Brand Name
gSource
Version/Model Number
gS 86.1605
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)
-
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
cdf7d1e8-e9a1-4307-afa5-8902ead3cefc
Public Version Date
September 02, 2022
Public Version Number
2
DI Record Publish Date
March 02, 2020
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 | 4617 |
2 | A medical device with a moderate to high risk that requires special controls. | 280 |