Duns Number:139105691
Device Description: Provident Direct Anterior Approach Broach Handle
Catalog Number
-
Brand Name
StelKast Generic Hip instruments
Version/Model Number
SC3781
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
4152798c-88ad-4d62-a0c2-3fcb29a89b16
Public Version Date
December 11, 2020
Public Version Number
2
DI Record Publish Date
April 18, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34645 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 232 |