Duns Number:131107757
Device Description: Single-use disposable orthopedic manual surgical instrument set
Catalog Number
-
Brand Name
ProChondrix® Instrument Set
Version/Model Number
58160-11
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 08, 2020
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
-
Product Code
HTW
Product Code Name
Bit, Drill
Public Device Record Key
9bd14e40-1597-44aa-811e-bb2ec87166f4
Public Version Date
June 09, 2020
Public Version Number
4
DI Record Publish Date
September 06, 2017
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |
| U | Unclassified | 5 |