Duns Number:080506581
Device Description: MAKE TO ORDER CANNULATED HEX SCREWDRIVER LONG 3.5mm
Catalog Number
299961786
Brand Name
NA
Version/Model Number
2999-61-786
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
646e4003-e457-4425-9fc5-67528fc685bf
Public Version Date
July 26, 2021
Public Version Number
1
DI Record Publish Date
July 16, 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 | 5254 |
2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
3 | A medical device with high risk that requires premarket approval | 908 |