Duns Number:042961576
Device Description: K-Wire, Double Ended Trocar Tip, 1.4mm x 150mm
Catalog Number
P99-292-1415
Brand Name
HammerTube System
Version/Model Number
P99-292-1415
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
K171715
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
7844f957-33e2-4290-a108-feed85b47c48
Public Version Date
October 25, 2019
Public Version Number
1
DI Record Publish Date
October 17, 2019
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 | 1122 |
2 | A medical device with a moderate to high risk that requires special controls. | 3564 |