Duns Number:121225812
Device Description: Topic Skin Adhesive - Exofin 1.0ml
Catalog Number
-
Brand Name
Exofin
Version/Model Number
M1205
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
K132243,K132243,K132243
Product Code
MPN
Product Code Name
Tissue Adhesive For The Topical Approximation Of Skin
Public Device Record Key
cd057fde-e155-4307-a214-025ddcca0d99
Public Version Date
July 09, 2020
Public Version Number
6
DI Record Publish Date
October 27, 2016
Package DI Number
10897392002968
Quantity per Package
6
Contains DI Package
00897392002237
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |