Duns Number:537619731
Catalog Number
-
Brand Name
Starter tap for screw, "line-to-line", Ø5mm
Version/Model Number
HAT40255
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
HWX
Product Code Name
Tap, Bone
Public Device Record Key
f1d57c91-7569-4ec4-a4c4-0e5eb145f2ed
Public Version Date
June 10, 2021
Public Version Number
4
DI Record Publish Date
June 29, 2017
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 | 191 |
2 | A medical device with a moderate to high risk that requires special controls. | 301 |
3 | A medical device with high risk that requires premarket approval | 49 |