Duns Number:342243334
Device Description: K-Wire w. double end trocarpoint 1.1mm/229mm, 6 pcs./unit fully thre K-Wire w. double end trocarpoint 1.1mm/229mm, 6 pcs./unit fully threaded
Catalog Number
KM71-302
Brand Name
K-Wire w. double end trocarpoint 1.1mm/229mm, 6 pcs./unit
Version/Model Number
KM71-302
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"
Yes
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
-
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
dc1c5332-2669-44fc-9998-a4e834e47a35
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 13, 2016
Package DI Number
EMAHKM713021
Quantity per Package
1
Contains DI Package
EMAHKM713020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1976 |