Duns Number:102726734
Device Description: Vac Via Dressing Small
Catalog Number
-
Brand Name
V.A.C.VIA™ GRANUFOAM™
Version/Model Number
VIAGFS05
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
K132741,K132741
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
965d7182-c4d2-494c-925a-93c137406f11
Public Version Date
September 09, 2020
Public Version Number
6
DI Record Publish Date
September 05, 2016
Package DI Number
00849554002319
Quantity per Package
5
Contains DI Package
00849554003774
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 |