Duns Number:196548481
Device Description: 11 gauge 15mm iVAS Elite Single Balloon Kit
Catalog Number
0808-115-000
Brand Name
iVAS
Version/Model Number
808115000
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
662b04a3-5fa0-466c-b996-e72d359f94b1
Public Version Date
July 09, 2020
Public Version Number
4
DI Record Publish Date
March 08, 2018
Package DI Number
37613327142717
Quantity per Package
3
Contains DI Package
07613327142716
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 |