Duns Number:102726734
Device Description: Vac Granufoam Bridge XG Dressing
Catalog Number
-
Brand Name
V.A.C.® GRANUFOAM™
Version/Model Number
M8275044/5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
5c182d6b-f58a-46ff-b542-6a7b5ed12b44
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
September 05, 2016
Package DI Number
00849554001022
Quantity per Package
5
Contains DI Package
00849554001961
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
5 Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 63 |