Duns Number:187502109
Device Description: 3/32" X 12" FEMORAL EYELOOP DRILL (QTY 6)
Catalog Number
234-020-023
Brand Name
NA
Version/Model Number
234-020-023
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
3c5c72e6-afd9-42aa-a32f-ff879867db1a
Public Version Date
November 22, 2018
Public Version Number
3
DI Record Publish Date
September 04, 2015
Package DI Number
34546540755415
Quantity per Package
6
Contains DI Package
04546540755414
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 |