Duns Number:320405061
Device Description: The “Vertebroplasty Needle Kit“, part of the Synthes’ Vertecem / Vertecem V+ System, is a The “Vertebroplasty Needle Kit“, part of the Synthes’ Vertecem / Vertecem V+ System, is a sterile packed kit for Vertebroplasty procedures. The needle kit is to be used in conjunction with PMMA cement and appropriate syringes.
Catalog Number
03.702.221S
Brand Name
Vertebroplasty Needle Kit, 12G, Beveled Tip
Version/Model Number
10001545US
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
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
FZX
Product Code Name
Guide, Surgical, Instrument
Public Device Record Key
b6c062dc-0bdd-48ed-821f-bd727045fe3e
Public Version Date
September 27, 2021
Public Version Number
2
DI Record Publish Date
April 15, 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 | 398 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |