Duns Number:005473608
Device Description: GC Fuji TRIAGE® Starter Package, White (1 x 50 capsule package, 1 x Capsule Applier, 1 x G GC Fuji TRIAGE® Starter Package, White (1 x 50 capsule package, 1 x Capsule Applier, 1 x GC CAVITY CONDITIONER, 1 x GC Fuji COAT LC)
Catalog Number
439991
Brand Name
GC Fuji TRIAGE®
Version/Model Number
439991
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
K013198,K013198
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
3285803d-6bcb-4541-a363-3acde3295274
Public Version Date
July 21, 2022
Public Version Number
1
DI Record Publish Date
July 13, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |