Duns Number:196548481
Device Description: System with Needle and Bone Cement
Catalog Number
0605-683-000
Brand Name
AutoPlex, VertaPlex
Version/Model Number
0605683000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2021
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
OAR
Product Code Name
Injector, vertebroplasty (does not contain cement)
Public Device Record Key
3b99174b-6f97-4995-aece-978b60f96810
Public Version Date
November 18, 2021
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
37613154687146
Quantity per Package
2
Contains DI Package
07613154687145
Package Discontinue Date
July 08, 2021
Package Status
Not 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 |