Duns Number:806136177
Device Description: SI AVANTI+ 7F STD W/GW NO OBT
Catalog Number
504607X
Brand Name
AVANTI
Version/Model Number
504607X
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"
Yes
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
DRE
Product Code Name
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Public Device Record Key
8100ab50-cc6b-4e8f-9f4f-0f937d42d763
Public Version Date
September 14, 2022
Public Version Number
7
DI Record Publish Date
August 01, 2016
Package DI Number
20705032010105
Quantity per Package
5
Contains DI Package
10705032010108
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2567 |
| 3 | A medical device with high risk that requires premarket approval | 204 |