Duns Number:187502109
Device Description: 2.4MM FEMORAL GUIDE PIN WITH FORK
Catalog Number
234-500-224
Brand Name
NA
Version/Model Number
234-500-224
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
HTW
Product Code Name
BIT, DRILL
Public Device Record Key
863a3ed8-6bcb-4891-a3db-f9f5e89ca88d
Public Version Date
November 22, 2018
Public Version Number
3
DI Record Publish Date
September 09, 2015
Package DI Number
34546540756955
Quantity per Package
6
Contains DI Package
04546540756954
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |