Duns Number:806754185
Device Description: ø3.2mm STEINMANN PIN, 9" DOUBLE END DIAMOND, FULLY THREADED
Catalog Number
HKW-23-090032
Brand Name
HNM MEDICAL
Version/Model Number
HKW-23-090032
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
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
K100736
Product Code
JDW
Product Code Name
Pin, Fixation, Threaded
Public Device Record Key
9c5efe74-149c-466f-9767-9fa3c537c322
Public Version Date
June 07, 2019
Public Version Number
1
DI Record Publish Date
May 30, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 729 |