Duns Number:005473608
Device Description: GC Fuji IX GP® Intro Package, 1-1 Pack,1 btl. Powder, Shade A2 (15g) 1 btl liquid (6.4ml), GC Fuji IX GP® Intro Package, 1-1 Pack,1 btl. Powder, Shade A2 (15g) 1 btl liquid (6.4ml), mixing pad
Catalog Number
000152
Brand Name
GC Fuji IX GP®
Version/Model Number
000152
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
-
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
K951555,K951555
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
770c4969-40de-4da4-ab6e-f62374f7b853
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
Package DI Number
24548161329634
Quantity per Package
5
Contains DI Package
14548161329637
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |