Duns Number:438746708
Device Description: Device for cement infusion in the vertebroplasty procedures
Catalog Number
KVTGUN-DS1
Brand Name
BIOPSYBELL
Version/Model Number
EASYNJECT
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
OAR
Product Code Name
Injector, Vertebroplasty (Does Not Contain Cement)
Public Device Record Key
fcb4eb43-e7b1-46a8-ae04-5c5ae96ddc13
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
08033860036591
Quantity per Package
2
Contains DI Package
08033860036584
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
POUCH
| 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 |