Duns Number:438746708
Device Description: KYPHOPLASTY DRILL
Catalog Number
RESDRI1312C
Brand Name
BIOPSYBELL
Version/Model Number
RENOVA SPINE KYPHOPLASTY DRILL
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"
Yes
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
HXY
Product Code Name
Brace, Drill
Public Device Record Key
573158ff-f1ee-46e6-a6d0-d174db23c32b
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
08033860038724
Quantity per Package
5
Contains DI Package
08033860038717
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BLISTER
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 41 |
2 | A medical device with a moderate to high risk that requires special controls. | 37 |