Duns Number:216861104
Catalog Number
7703006
Brand Name
Avance
Version/Model Number
7703006-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 13, 2018
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OMP
Product Code Name
negative pressure wound therapy Powered suction pump
Public Device Record Key
6f2f82fb-ba32-4f18-adcd-d5672bc0089d
Public Version Date
December 08, 2020
Public Version Number
4
DI Record Publish Date
August 18, 2017
Package DI Number
07323190130948
Quantity per Package
1
Contains DI Package
07323190130917
Package Discontinue Date
August 13, 2018
Package Status
Not 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. | 7 |