Duns Number:196548481
Device Description: Precision System with Extension Tube and Bone Cement
Catalog Number
0507-486-000
Brand Name
PCD, VertaPlex
Version/Model Number
0507486000
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
NDN
Product Code Name
CEMENT, BONE, VERTEBROPLASTY
Public Device Record Key
5dec84a8-8950-48de-a32a-2f98ef866542
Public Version Date
August 01, 2019
Public Version Number
4
DI Record Publish Date
April 21, 2017
Package DI Number
37613327357869
Quantity per Package
4
Contains DI Package
07613327357868
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |