Duns Number:079163089
Device Description: eXofin Precision Pen High Viscosity Topical Skin Adhesive
Catalog Number
EP70412
Brand Name
eXofin Precision Pen, 1g
Version/Model Number
EP70412
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
K212246,K212246
Product Code
MPN
Product Code Name
Tissue Adhesive For The Topical Approximation Of Skin
Public Device Record Key
ffd92c3d-61a0-4dc7-b044-b977cb1cffa0
Public Version Date
February 15, 2022
Public Version Number
2
DI Record Publish Date
November 10, 2021
Package DI Number
00854137001641
Quantity per Package
12
Contains DI Package
00854137001634
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
| 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 |