Duns Number:650051832
Device Description: Cerdak Aerocloth 45 x 150 mm
Catalog Number
-
Brand Name
Cerdak
Version/Model Number
Cerdak Aerocloth
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
K153138,K153138,K153138
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
d41e8cea-47d5-4c3e-8f24-7010e667e9e5
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
January 18, 2018
Package DI Number
18903389005187
Quantity per Package
10
Contains DI Package
58903389005185
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-