Duns Number:829465157
Device Description: Dermabond Prineo Skin Closure System
Catalog Number
CLR222US
Brand Name
DERMABOND PRINEO
Version/Model Number
CLR222US
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
-
Product Code
OMD
Product Code Name
Cutaneous tissue adhesive with mesh
Public Device Record Key
b0d2d191-33ff-4faf-9853-8d8d5cd53e25
Public Version Date
December 08, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2015
Package DI Number
20705031230993
Quantity per Package
2
Contains DI Package
10705031230996
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |