Duns Number:079163089
Device Description: exofin Fusion Skin Closure System, 30cm
Catalog Number
EF70430
Brand Name
exofin Fusion Skin Closure System, 30cm
Version/Model Number
EF70430
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171442,K171442
Product Code
OMD
Product Code Name
Cutaneous Tissue Adhesive With Mesh
Public Device Record Key
06f71087-2e26-4d50-a2c8-d03f5eb68d3a
Public Version Date
May 16, 2022
Public Version Number
2
DI Record Publish Date
February 14, 2022
Package DI Number
20854137001492
Quantity per Package
2
Contains DI Package
00854137001498
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |