Duns Number:831375089
Device Description: PremierPro exofin® Precision Pen 1.0g (1.0ml)
Catalog Number
3475
Brand Name
PremierPro
Version/Model Number
3475
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"
Yes
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
d11c7302-fb2d-4b53-ac36-e9b695df628d
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 14, 2022
Package DI Number
00811220033538
Quantity per Package
12
Contains DI Package
00811220033521
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |