Duns Number:017663522
Catalog Number
6203-00
Brand Name
Blunt K-Wire
Version/Model Number
6203-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 23, 2016
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
HXI
Product Code Name
Passer, Wire, Orthopedic
Public Device Record Key
6c9cf320-f1ac-4020-bb84-7c20ff9a56ea
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2015
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 | 150 |
2 | A medical device with a moderate to high risk that requires special controls. | 132 |
U | Unclassified | 13 |