Duns Number:216344051
Device Description: Polyethylene wound contact layer
Catalog Number
5955044
Brand Name
CONFORMANT 2 WND VL4X4IN CS48
Version/Model Number
5955044
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
46760c57-6546-440a-aa98-37230ef1b80f
Public Version Date
July 24, 2020
Public Version Number
1
DI Record Publish Date
July 16, 2020
Package DI Number
30040565119305
Quantity per Package
48
Contains DI Package
00040565119304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |