Duns Number:102726734
Device Description: KCI NPWT Gauze Dressing Large Featuring Sensatrac Technology
Catalog Number
-
Brand Name
V.A.C.®
Version/Model Number
413716
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
62f36895-f6ed-4fbc-ae65-c7b58a1ac171
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
September 05, 2016
Package DI Number
00849554001251
Quantity per Package
5
Contains DI Package
00849554001336
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 |