Duns Number:102726734
Device Description: Vac Abdominal Dressing Featuring Sensatrac Technology
Catalog Number
-
Brand Name
V.A.C.®
Version/Model Number
M8275080/5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 08, 2018
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
K022011,K022011
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
b4a1da48-cb07-4f6a-b5b2-7ccd900cf363
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
September 05, 2016
Package DI Number
00878237001424
Quantity per Package
5
Contains DI Package
00849554002562
Package Discontinue Date
June 08, 2018
Package Status
Not 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 |