Duns Number:315768788
Device Description: Zetuvit Plus 25x20 P10
Catalog Number
-
Brand Name
Zetuvit Plus 25x20 P10
Version/Model Number
Zetuvit Plus 25x20 P10
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)
Yes
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
ed6ba1e2-b68c-461f-87c4-eb65a239bc43
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
September 01, 2020
Package DI Number
04052199503745
Quantity per Package
10
Contains DI Package
04052199507286
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 99 |
U | Unclassified | 1 |