Duns Number:196548481
Device Description: 20 Gram Twin Pack (1/2 dose)
Catalog Number
0406-622-015
Brand Name
VertaPlex HV
Version/Model Number
0406622015
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
3eae6a82-d778-432c-90bb-68a4eb4add9d
Public Version Date
October 09, 2020
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
57613327170554
Quantity per Package
22
Contains DI Package
07613327170559
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| 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 |